Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01218113
• Collaborator: (none)
• Enrollment: 191
• Locations: 42
• Arms: 3
• Actual Duration (Months): 23.9
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

Condition or Disease	Intervention/Treatment	Phase
AIDS	Biological: GSK Biologicals HIV Vaccine 732462; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 191 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons
• Actual Study Start Date: Nov 8, 2010
• Actual Primary Completion Date: Nov 5, 2012
• Actual Study Completion Date: Nov 5, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D_HIV Group HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	Biological: GSK Biologicals HIV Vaccine 732462; 2 or 3 doses according to protocol schedule
Experimental: 2D_HIV Group HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	Biological: GSK Biologicals HIV Vaccine 732462; 2 or 3 doses according to protocol schedule; Drug: Placebo; 1 or 3 doses according to protocol schedule
Placebo Comparator: Control Group HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	Drug: Placebo; 1 or 3 doses according to protocol schedule

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline [At Week 48, post-Dose 3]

   Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter [copies/mL]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.

2. Geometric Mean Change in HIV-1 VL From Baseline [At Week 48, post-Dose 3]

   Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.

3. Number of Subjects With Solicited Local Symptoms [During the 7-day (Days 0-6) period following Dose 1]

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

4. Number of Subjects With Solicited Local Symptoms [During the 7-day (Days 0-6) period following Dose 2]

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

5. Number of Subjects With Solicited Local Symptoms [During the 7-day (Days 0-6) period following Dose 3]

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

6. Number of Subjects With Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period, across doses]

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

7. Number of Subjects With Solicited General Symptoms [During the 7-day (Days 0-6) period following Dose 1]

   Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

8. Number of Subjects With Solicited General Symptoms [During the 7-day (Days 0-6) period following Dose 2]

   Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

9. Number of Subjects With Solicited General Symptoms [During the 7-day (Days 0-6) period following Dose 3]

   Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

10. Number of Subjects With Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period, across doses]

    Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

11. Number of Subjects With Unsolicited Adverse Events (AEs) [During the 28-Day (Days 0-27) period following Dose 1 and Dose 2]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 1 and Dose 2 vaccinations.

12. Number of Subjects With Unsolicited AEs [During the 28-Day (Days 0-27) post-vaccination period]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 3 and across doses.

13. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (up to Week 48)]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

14. Number of Subjects With Potentially Immune-Mediated Diseases (pIMDs) [During the entire study period (up to Week 48)]

    Potentially Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

15. Number of Subjects With Abnormal Haematological and Biochemical Values [At Screening]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

16. Number of Subjects With Abnormal Haematological and Biochemical Values [Pre-vaccination, at Week 0]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

17. Number of Subjects With Abnormal Haematological and Biochemical Values [At Week 4]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

18. Number of Subjects With Abnormal Haematological and Biochemical Values [At Week 6]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

19. Number of Subjects With Abnormal Haematological and Biochemical Values [At Week 16]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

20. Number of Subjects With Abnormal Haematological and Biochemical Values [At Week 28]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

21. Number of Subjects With Abnormal Haematological and Biochemical Values [At Week 30]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

22. Number of Subjects With Abnormal Haematological and Biochemical Values [At Week 38]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

23. Number of Subjects With Abnormal Haematological and Biochemical Values [At Week 48]

    Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

Secondary Outcome Measures

1. Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline [At Weeks 1, 4, 6, 16, 28, 30 and 38]

   Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/mL. Baseline of HIV-1 viral load was defined as the geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 28 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.

2. Geometric Mean Change in HIV-1 VL From Baseline [At Weeks 1, 4, 6, 16, 28, 30 and 38]

   Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 29 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.

3. Levels of HIV-1 Viral Load (VL) [At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48]

   HIV-1 VL, using crude values, was expressed in RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.

4. Levels of HIV-1 VL [At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48]

   HIV-1 VL, using log10 transformed values, was expressed in log10-RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.

5. Percentage of Subjects With Plasmatic HIV-1 Viral Load Decrease Higher Than (>) 1 [At Week 48]

   The proportion of subjects with >1 decrease of HIV-1 VL, was determined using log10-transformed values.

6. Cluster of Differentiation 4 (CD4) Absolute Cell Count [At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48]

   Result determination, using crude values, was done from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening (SCR) to Week (W) 48 for the Control Group.

7. Mean Change in CD4 Cell Count From Baseline [At Weeks 1, 4, 6, 16, 28, 30, 38 and 48]

   Baseline for CD4 cell count analysis was defined as the mean of values measured in blood taken at Screening and at pre vaccination (PRE). Result determination, using crude values, was done from week 1 to 28 for the HIV Group, weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from week 1 to week 48 for the Control Group.

8. Percentage of Subjects With ART (Anti-Retroviral Therapy) Initiation and HIV-related Clinical Events [During the entire study period (up to Week 48)]

   Only actual ART initiations were reported under the category "ART initiation". HIV-related clinical events were defined as: clinical disease progression, or confirmed VL > 100.000 copies/mL, or confirmed CD4 cell count < 350 cells/ cubic millimeter (mm3).

9. Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2) [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

   Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2), as assessed by Intracellular Cytokine Staining (ICS).

10. Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

11. Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine. [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L-CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L-CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

12. Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

13. Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD8+ T-cells and F4co-Computed [frequency of CD8+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD8+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).

14. Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Breadth was assessed only for the CD4+ T-cells and was measured by evaluating response to at least 1, 2, 3 or all 4 antigens: proteins 17, 24, Nef, reverse transcriptase (RT).

15. Cytokine Expression Profile of F4co-Computed CD4+ T Cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of F4co-Computed CD4+ T-cells [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

16. Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of Nef-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

17. Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of P17-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

18. Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of P24-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

19. Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).

20. Cytokine Expression Profile of F4co-Computed CD8+ T Cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of F4co-Computed CD8+ T-cells [Frequency of CD8+ T cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

21. Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of Nef-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

22. Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of P17-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

23. Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of P24-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

24. Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.

25. Number of Seropositive Subjects for Anti-P17 Antibodies [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Seropositivity rates for antibodies against P17 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 187 milli-ELISA units per milliliter (mEL.U/mL).

26. Number of Seropositive Subjects for Anti-P24 Antibodies [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Seropositivity rates for antibodies against P24 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 119 milli-ELISA units per milliliter (mEL.U/mL).

27. Number of Seropositive Subjects for Anti-Nef Antibodies [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Seropositivity rates for antibodies against Nef antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 494 milli-ELISA units per milliliter (mEL.U/mL).

28. Number of Seropositive Subjects for Anti-RT Antibodies [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Seropositivity rates for antibodies against RT antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 125 milli-ELISA units per milliliter (mEL.U/mL).

29. Number of Seropositive Subjects for Anti-F4co Antibodies [During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)]

    Seropositivity rates for antibodies against F4co antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 42 milli-ELISA units per milliliter (mEL.U/mL).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject prior to any study procedure.

• A male or female between and including 18-55 years at the time of first vaccination.

• Known to be HIV-1 infected and under the care of an HIV physician for a minimum of 6 months. However, subjects who initially presented with a clinical diagnosis of primary HIV infection need to have been diagnosed and under care for at least 12 months.

• ART-naïve. Individuals must never have received ART after HIV diagnosis, including lamivudine used for chronic hepatitis B infection, with the exception of short-term ART for prevention of mother-to-child transmission (PMTCT) at least 12 months prior to enrollment.

• Commencement of ART is not expected, based on current assessment, within the next 12 months.

• Viral load level of 2,000-80,000 copies/mL at screening.

• CD4 count >= 500 cells per mm3 at screening.

• If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test at screening, and

• has agreed to continue adequate contraception during the entire study period.

Exclusion Criteria:

The following criteria should be checked at the time of screening and before vaccination.

If ANY exclusion criterion applies, the subject must not be included in the study:

• Infection with HIV-2. This includes patients with dual infection with HIV-1/HIV-2.

• Had an Acquired Immune Deficiency Syndrome (AIDS) defining clinical illness.

• Use of any investigational or non-registered product within 4 weeks preceding the first dose of study vaccine/placebo, or planned use of any investigational or non-registered product other than the study vaccine during the study period.

• Drug therapy with immunomodulators or steroids within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period. Acute use of steroids up to 4 weeks preceding the first dose for treatment of hypersensitivity reactions is not an exclusion criterion. Inhaled and topical steroids are allowed.

• Administration of immunoglobulins and/ or any blood products within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period.

• Planned administration of a vaccine not foreseen by the study protocol during

• the period starting 2 weeks before the first dose of study vaccine/placebo and ending at Visit 3 (Week 6) (after blood sampling),

• the period starting from 2 weeks prior to Visit 5 (Week 28) and ending at Visit 6 (Week 30) (after blood sampling)

• the period starting from 2 weeks prior to Visit 8 (Week 48) and ending at Visit 8 (Week 48) (after blood sampling), with the exception of non-adjuvanted influenza vaccine.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Any previous vaccination or immunotherapy against HIV.

• A family history of hereditary immunodeficiency.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Acute or chronic infective hepatitis.

• Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and/or medical history at screening.

• Grade 3 or grade 4 laboratory abnormality, as defined by Division od AIDS (DAIDS) grading table, at screening

• Pregnant or lactating female.

• Any condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

• History of medically confirmed autoimmune disease.

• History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.

• Unstable asthma

• Food or wine induced asthma.

• Known sensitivity to sulfites or aspirin.

• Known sensitivity to aminoglycoside antibiotics.

• Contraindication to intramuscular injection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bakersfield	California	United States	93301
2	GSK Investigational Site	Long Beach	California	United States	90813
3	GSK Investigational Site	Washington	District of Columbia	United States	20037
4	GSK Investigational Site	Fort Lauderdale	Florida	United States	33308
5	GSK Investigational Site	Jacksonville	Florida	United States	32216
6	GSK Investigational Site	Orlando	Florida	United States	32804
7	GSK Investigational Site	Omaha	Nebraska	United States	68198
8	GSK Investigational Site	Camden	New Jersey	United States	08103
9	GSK Investigational Site	Newark	New Jersey	United States	07102
10	GSK Investigational Site	Somers Point	New Jersey	United States	08244
11	GSK Investigational Site	Columbus	Ohio	United States	43210
12	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
13	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19107
14	GSK Investigational Site	Johnson City	Tennessee	United States	37604
15	GSK Investigational Site	Dallas	Texas	United States	75246
16	GSK Investigational Site	Annandale	Virginia	United States	22003
17	GSK Investigational Site	Seattle	Washington	United States	98122-4299
18	GSK Investigational Site	Bobigny		France	93009
19	GSK Investigational Site	Créteil		France	94010
20	GSK Investigational Site	Nantes		France	44093
21	GSK Investigational Site	Paris Cedex 10		France	75475
22	GSK Investigational Site	Paris Cedex 12		France	75571
23	GSK Investigational Site	Paris Cedex 13		France	75651
24	GSK Investigational Site	Paris cedex 15		France	75908
25	GSK Investigational Site	Paris Cedex 20		France	75970
26	GSK Investigational Site	Paris		France	75018
27	GSK Investigational Site	Paris		France	75679
28	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
29	GSK Investigational Site	Erlangen	Bayern	Germany	91054
30	GSK Investigational Site	Muenchen	Bayern	Germany	80331
31	GSK Investigational Site	Muenchen	Bayern	Germany	80801
32	GSK Investigational Site	Muenchen	Bayern	Germany	81371
33	GSK Investigational Site	Bochum	Nordrhein-Westfalen	Germany	44791
34	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45122
35	GSK Investigational Site	Berlin		Germany	13353
36	GSK Investigational Site	Badalona		Spain	08916
37	GSK Investigational Site	Barcelona		Spain	08036
38	GSK Investigational Site	Barcelona		Spain	08907
39	GSK Investigational Site	Madrid		Spain	28034
40	GSK Investigational Site	Madrid		Spain	28041
41	GSK Investigational Site	Móstoles, Madrid		Spain	28935
42	GSK Investigational Site	Valencia		Spain	46014

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01218113
• Other Study ID Numbers: 111679
• First Posted: Oct 11, 2010
• Last Update Posted: May 21, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by GlaxoSmithKline: Human Immunodeficiency Virus (HIV)-1; safety; vaccine; immunogenicity; reactogenicity; HIV infection

Study Results

Participant Flow

Pre-assignment Detail	Out of 191 subjects originally enrolled in the study, only 190 subjects received vaccination and were hence included in the Total Vaccinated Cohort.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Period Title: Overall Study
STARTED	62	64	64
COMPLETED	57	63	58
NOT COMPLETED	5	1	6

Baseline Characteristics

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group	Total
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	Total of all reporting groups
Overall Participants	62	64	64	190
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	34.9 (7.6)	37.0 (8.2)	35.9 (8.4)	35.9 (8.1)
Sex: Female, Male (Count of Participants)
Female	9 14.5%	10 15.6%	10 15.6%	29 15.3%
Male	53 85.5%	54 84.4%	54 84.4%	161 84.7%
Race/Ethnicity, Customized (Count of Participants)
African heritage/African American	11 17.7%	10 15.6%	15 23.4%	36 18.9%
American Indian or Alaskan Native	0 0%	0 0%	2 3.1%	2 1.1%
White-Arabic/North African heritage	4 6.5%	3 4.7%	3 4.7%	10 5.3%
White-Caucasian/European heritage	43 69.4%	51 79.7%	42 65.6%	136 71.6%
Other	4 6.5%	0 0%	2 3.1%	6 3.2%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline
Description	Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter [copies/mL]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.
Time Frame	At Week 48, post-Dose 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	46	55	50
Geometric Mean (Standard Deviation) [RNA copies/mL]	1.0 (0.35)	1.5 (0.38)	1.3 (0.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	3D_HIV Group, Control Group
	Comments	To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.
	Type of Statistical Test	Non-Inferiority
	Comments	Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D_HIV Group - Control Group) is below 0.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.801
	Confidence Interval	(2-Sided) 97.5%; 0.553 to 1.162
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	2D_HIV Group, Control Group
	Comments	To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.
	Type of Statistical Test	Non-Inferiority
	Comments	Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D_HIV Group - Control Group) is below 0.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.184
	Confidence Interval	(2-Sided) 97.5%; 0.816 to 1.717
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Geometric Mean Change in HIV-1 VL From Baseline
Description	Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.
Time Frame	At Week 48, post-Dose 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	46	55	50
Geometric Mean (Standard Deviation) [log10(RNA copies/mL)]	0.0 (0.35)	0.2 (0.38)	0.1 (0.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	3D_HIV Group, Control Group
	Comments	To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 3 doses of the HIV Vaccine 732462 and persons who received placebo alone.
	Type of Statistical Test	Non-Inferiority
	Comments	Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D_HIV Group - Control Group) is below 0.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.096
	Confidence Interval	(2-Sided) 97.5%; -0.257 to 0.065
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	2D_HIV Group, Control Group
	Comments	To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.
	Type of Statistical Test	Non-Inferiority
	Comments	Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D_HIV Group - Control Group) is below 0.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	0.073
	Confidence Interval	(2-Sided) 97.5%; -0.088 to 0.235
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Number of Subjects With Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Time Frame	During the 7-day (Days 0-6) period following Dose 1

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	125	63
Any Pain, Dose 1	112 180.6%	12 18.8%
Grade 3 Pain, Dose 1	9 14.5%	0 0%
Medically attended Pain, Dose 1	0 0%	0 0%
Any Redness, Dose 1	16 25.8%	0 0%
Grade 3 Redness, Dose 1	0 0%	0 0%
Medically attended Redness, Dose 1	0 0%	0 0%
Any Swelling, Dose 1	7 11.3%	0 0%
Grade 3 Swelling, Dose 1	0 0%	0 0%
Medically attended Swelling, Dose 1	0 0%	0 0%

4. Primary Outcome

Title	Number of Subjects With Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Time Frame	During the 7-day (Days 0-6) period following Dose 2

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	120	61
Any Pain, Dose 2	98 158.1%	5 7.8%
Grade 3 Pain, Dose 2	11 17.7%	0 0%
Medically Attended Pain, Dose 2	0 0%	0 0%
Any Redness, Dose 2	15 24.2%	0 0%
Grade 3 Redness, Dose 2	0 0%	0 0%
Medically Attended Redness, Dose 2	0 0%	0 0%
Any Swelling, Dose 2	6 9.7%	0 0%
Grade 3 Swelling, Dose 2	0 0%	0 0%
Medically Attended Swelling, Dose 2	0 0%	0 0%

5. Primary Outcome

Title	Number of Subjects With Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Time Frame	During the 7-day (Days 0-6) period following Dose 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	55	58	54
Any Pain, Dose 3	42 67.7%	9 14.1%	3 4.7%
Grade 3 Pain, Dose 3	6 9.7%	0 0%	0 0%
Medically attended Pain, Dose 3	0 0%	0 0%	0 0%
Any Redness, Dose 3	10 16.1%	0 0%	0 0%
Grade 3 Redness, Dose 3	0 0%	0 0%	0 0%
Medically attended Redness, Dose 3	0 0%	0 0%	0 0%
Any Swelling, Dose 3	3 4.8%	0 0%	0 0%
Grade 3 Swelling, Dose 3	0 0%	0 0%	0 0%
Medically attended Swelling, Dose 3	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Number of Subjects With Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.
Time Frame	During the 7-day (Days 0-6) post-vaccination period, across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	62	64	64
Any Pain, Across doses	58 93.5%	57 89.1%	14 21.9%
Grade 3 Pain, Across doses	15 24.2%	6 9.4%	0 0%
Medically Attended Pain, Across doses	0 0%	0 0%	0 0%
Any Redness, Across doses	17 27.4%	14 21.9%	0 0%
Grade 3 Redness, Across doses	0 0%	0 0%	0 0%
Medically Attended Redness, Across doses	0 0%	0 0%	0 0%
Any Swelling, Across doses	4 6.5%	8 12.5%	0 0%
Grade 3 Swelling, Across doses	0 0%	0 0%	0 0%
Medically Attended Swelling, Across doses	0 0%	0 0%	0 0%

7. Primary Outcome

Title	Number of Subjects With Solicited General Symptoms
Description	Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Time Frame	During the 7-day (Days 0-6) period following Dose 1

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	124	63
Any Abdominal pain, Dose 1	14 22.6%	3 4.7%
Grade 3 Abdominal pain, Dose 1	0 0%	0 0%
Related Abdominal pain, Dose 1	2 3.2%	0 0%
Grade 3 Related Abdominal pain, Dose 1	0 0%	0 0%
Medically Attended Abdominal pain, Dose 1	1 1.6%	0 0%
Any Anorexia, Dose 1	7 11.3%	2 3.1%
Grade 3 Anorexia, Dose 1	0 0%	0 0%
Related Anorexia, Dose 1	4 6.5%	0 0%
Grade 3 Related Anorexia, Dose 1	0 0%	0 0%
Medically Attended Anorexia, Dose 1	0 0%	0 0%
Any Diarrhoea, Dose 1	16 25.8%	5 7.8%
Grade 3 Diarrhoea, Dose 1	1 1.6%	0 0%
Related Diarrhoea, Dose 1	1 1.6%	0 0%
Grade 3 Related Diarrhoea, Dose 1	0 0%	0 0%
Medically Attended Diarrhoea, Dose 1	1 1.6%	0 0%
Any Fatigue, Dose 1	56 90.3%	16 25%
Grade 3 Fatigue, Dose 1	3 4.8%	1 1.6%
Related Fatigue, Dose 1	24 38.7%	7 10.9%
Grade 3 Related Fatigue, Dose 1	1 1.6%	0 0%
Medically Attended Fatigue, Dose 1	0 0%	0 0%
Any Headache, Dose 1	40 64.5%	14 21.9%
Grade 3 Headache, Dose 1	4 6.5%	1 1.6%
Related Headache, Dose 1	16 25.8%	8 12.5%
Grade 3 Related Headache, Dose 1	4 6.5%	0 0%
Medically Attended Headache, Dose 1	0 0%	1 1.6%
Any Myalgia, Dose 1	44 71%	9 14.1%
Grade 3 Myalgia, Dose 1	2 3.2%	0 0%
Related Myalgia, Dose 1	26 41.9%	4 6.3%
Grade 3 Related Myalgia, Dose 1	1 1.6%	0 0%
Medically Attended Myalgia, Dose 1	0 0%	0 0%
Any Nausea, Dose 1	17 27.4%	5 7.8%
Grade 3 Nausea, Dose 1	1 1.6%	0 0%
Related Nausea, Dose 1	4 6.5%	2 3.1%
Grade 3 Related Nausea, Dose 1	0 0%	0 0%
Medically Attended Nausea, Dose 1	0 0%	0 0%
Any Sweating, Dose 1	16 25.8%	6 9.4%
Grade 3 Sweating, Dose 1	1 1.6%	0 0%
Related Sweating, Dose 1	3 4.8%	1 1.6%
Grade 3 Related Sweating, Dose 1	0 0%	0 0%
Medically Attended Sweating, Dose 1	0 0%	0 0%
Any Temperature, Dose 1	8 12.9%	2 3.1%
Grade 3 Temperature, Dose 1	1 1.6%	0 0%
Related Temperature, Dose 1	3 4.8%	0 0%
Grade 3 Related Temperature, Dose 1	0 0%	0 0%
Medically Attended Temperature, Dose 1	1 1.6%	0 0%
Any Vomiting, Dose 1	2 3.2%	1 1.6%
Grade 3 Vomiting, Dose 1	0 0%	0 0%
Related Vomiting, Dose 1	1 1.6%	0 0%
Grade 3 Related Vomiting, Dose 1	0 0%	0 0%
Medically Attended Vomiting, Dose 1	0 0%	0 0%

8. Primary Outcome

Title	Number of Subjects With Solicited General Symptoms
Description	Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Time Frame	During the 7-day (Days 0-6) period following Dose 2

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	120	61
Any Abdominal pain, Dose 2	9 14.5%	1 1.6%
Grade 3 Abdominal Pain, Dose 2	1 1.6%	0 0%
Related Abdominal Pain, Dose 2	3 4.8%	0 0%
Grade 3 Related Abdominal Pain, Dose 2	0 0%	0 0%
Medically Attended Abdominal Pain, Dose 2	1 1.6%	0 0%
Any Anorexia, Dose 2	7 11.3%	2 3.1%
Grade 3 Anorexia, Dose 2	1 1.6%	0 0%
Related Anorexia, Dose 2	3 4.8%	0 0%
Grade 3 Related Anorexia, Dose 2	0 0%	0 0%
Medically Attended Anorexia, Dose 2	1 1.6%	0 0%
Any Diarrhoea, Dose 2	13 21%	7 10.9%
Grade 3 Diarrhoea, Dose 2	0 0%	0 0%
Related Diarrhoea, Dose 2	2 3.2%	1 1.6%
Grade 3 Related Diarrhoea, Dose 2	0 0%	0 0%
Medically Attended Diarrhoea, Dose 2	0 0%	0 0%
Any Fatigue, Dose 2	56 90.3%	10 15.6%
Grade 3 Fatigue, Dose 2	6 9.7%	2 3.1%
Related Fatigue, Dose 2	25 40.3%	4 6.3%
Grade 3 Related Fatigue, Dose 2	4 6.5%	1 1.6%
Medically Attended Fatigue, Dose 2	2 3.2%	0 0%
Any Headache, Dose 2	34 54.8%	8 12.5%
Grade 3 Headache, Dose 2	5 8.1%	1 1.6%
Related Headache, Dose 2	15 24.2%	3 4.7%
Grade 3 Related Headache, Dose 2	3 4.8%	0 0%
Medically Attended Headache, Dose 2	1 1.6%	0 0%
Any Myalgia, Dose 2	42 67.7%	6 9.4%
Grade 3 Myalgia, Dose 2	6 9.7%	1 1.6%
Related Myalgia, Dose 2	26 41.9%	1 1.6%
Grade 3 Related Myalgia, Dose 2	6 9.7%	0 0%
Medically Attended Myalgia, Dose 2	1 1.6%	1 1.6%
Any Nausea, Dose 2	11 17.7%	0 0%
Grade 3 Nausea, Dose 2	0 0%	0 0%
Related Nausea, Dose 2	4 6.5%	0 0%
Grade 3 Related Nausea, Dose 2	0 0%	0 0%
Medically Attended Nausea, Dose 2	1 1.6%	0 0%
Any Sweating, Dose 2	17 27.4%	3 4.7%
Grade 3 Sweating, Dose 2	2 3.2%	0 0%
Related Sweating, Dose 2	8 12.9%	0 0%
Grade 3 Related Sweating, Dose 2	2 3.2%	0 0%
Medically Attended Sweating, Dose 2	1 1.6%	0 0%
Any Temperature, Dose 2	11 17.7%	3 4.7%
Grade 3 Temperature, Dose 2	0 0%	0 0%
Related Temperature, Dose 2	7 11.3%	0 0%
Grade 3 Related Temperature, Dose 2	0 0%	0 0%
Medically Attended Temperature, Dose 2	1 1.6%	1 1.6%
Any Vomiting, Dose 2	2 3.2%	1 1.6%
Grade 3 Vomiting, Dose 2	0 0%	0 0%
Related Vomiting, Dose 2	0 0%	0 0%
Grade 3 Related Vomiting, Dose 2	0 0%	0 0%
Medically Attended Vomiting, Dose 2	0 0%	0 0%

9. Primary Outcome

Title	Number of Subjects With Solicited General Symptoms
Description	Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Time Frame	During the 7-day (Days 0-6) period following Dose 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	56	58	54
Any Abdominal pain, Dose 3	4 6.5%	4 6.3%	2 3.1%
Grade 3 Abdominal pain, Dose 3	0 0%	2 3.1%	0 0%
Related Abdominal pain, Dose 3	1 1.6%	1 1.6%	0 0%
Grade 3 Related Abdominal pain, Dose 3	0 0%	1 1.6%	0 0%
Medically Attende Abdominal pain, Dose 3	1 1.6%	1 1.6%	0 0%
Any Anorexia, Dose 3	7 11.3%	3 4.7%	3 4.7%
Grade 3 Anorexia, Dose 3	0 0%	0 0%	0 0%
Related Anorexia, Dose 3	3 4.8%	0 0%	0 0%
Grade 3 Related Anorexia, Dose 3	0 0%	0 0%	0 0%
Medically Attended Anorexia, Dose 3	0 0%	0 0%	0 0%
Any Diarrhoea, Dose 3	8 12.9%	12 18.8%	5 7.8%
Grade 3 Diarrhoea, Dose 3	0 0%	0 0%	1 1.6%
Related Diarrhoea, Dose 3	4 6.5%	3 4.7%	1 1.6%
Grade 3 Related Diarrhoea, Dose 3	0 0%	0 0%	0 0%
Medically Attended Diarrhoea, Dose 3	1 1.6%	0 0%	0 0%
Any Fatigue, Dose 3	25 40.3%	11 17.2%	8 12.5%
Grade 3 Fatigue, Dose 3	3 4.8%	2 3.1%	1 1.6%
Related Fatigue, Dose 3	15 24.2%	3 4.7%	2 3.1%
Grade 3 Related Fatigue, Dose 3	1 1.6%	0 0%	0 0%
Medically Attended Fatigue, Dose 3	0 0%	0 0%	0 0%
Any Headache, Dose 3	16 25.8%	17 26.6%	7 10.9%
Grade 3 Headache, Dose 3	1 1.6%	1 1.6%	0 0%
Related Headache, Dose 3	8 12.9%	5 7.8%	1 1.6%
Grade 3 Related Headache, Dose 3	1 1.6%	0 0%	0 0%
Medically Attended Headache, Dose 3	2 3.2%	1 1.6%	0 0%
Any Myalgia, Dose 3	19 30.6%	9 14.1%	4 6.3%
Grade 3 Myalgia, Dose 3	2 3.2%	1 1.6%	0 0%
Related Myalgia, Dose 3	13 21%	3 4.7%	1 1.6%
Grade 3 Related Myalgia, Dose 3	1 1.6%	0 0%	0 0%
Medically Attended Myalgia, Dose 3	0 0%	1 1.6%	0 0%
Any Nausea, Dose 3	7 11.3%	2 3.1%	3 4.7%
Grade 3 Nausea, Dose 3	0 0%	0 0%	0 0%
Related Nausea, Dose 3	3 4.8%	0 0%	0 0%
Grade 3 Related Nausea, Dose 3	0 0%	0 0%	0 0%
Medically Attended Nausea, Dose 3	0 0%	0 0%	0 0%
Any Sweating, Dose 3	7 11.3%	8 12.5%	2 3.1%
Grade 3 Sweating, Dose 3	0 0%	0 0%	0 0%
Related Sweating, Dose 3	4 6.5%	1 1.6%	0 0%
Grade 3 Related Sweating, Dose 3	0 0%	0 0%	0 0%
Medically Attended Sweating, Dose 3	0 0%	0 0%	0 0%
Any Temperature, Dose 3	5 8.1%	3 4.7%	1 1.6%
Grade 3 Temperature, Dose 3	1 1.6%	0 0%	0 0%
Related Temperature, Dose 3	4 6.5%	0 0%	0 0%
Grade 3 Related Temperature, Dose 3	1 1.6%	0 0%	0 0%
Medically Attended Temperature, Dose 3	0 0%	0 0%	0 0%
Any Vomiting, Dose 3	2 3.2%	0 0%	1 1.6%
Grade 3 Vomiting, Dose 3	0 0%	0 0%	0 0%
Related Vomiting, Dose 3	1 1.6%	0 0%	0 0%
Grade 3 Related Vomiting, Dose 3	0 0%	0 0%	0 0%
Medically Attended Vomiting, Dose 3	0 0%	0 0%	0 0%

10. Primary Outcome

Title	Number of Subjects With Solicited General Symptoms
Description	Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination
Time Frame	During the 7-day (Days 0-6) post-vaccination period, across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	62	64	64
Any Abdominal pain, Across doses	13 21%	10 15.6%	4 6.3%
Grade 3 Abdominal pain, Across doses	1 1.6%	2 3.1%	0 0%
Related Abdominal pain, Across doses	3 4.8%	3 4.7%	0 0%
Grade 3 Related Abdominal pain, Across doses	0 0%	1 1.6%	0 0%
Medically Attended Abdominal pain, Across doses	3 4.8%	1 1.6%	0 0%
Any Anorexia, Across doses	11 17.7%	10 15.6%	7 10.9%
Grade 3 Anorexia, Across doses	1 1.6%	0 0%	0 0%
Related Anorexia, Across doses	5 8.1%	4 6.3%	0 0%
Grade 3 Related Anorexia, Across doses	0 0%	0 0%	0 0%
Medically Attended Anorexia, Across doses	0 0%	1 1.6%	0 0%
Any Diarrhoea, Across doses	17 27.4%	19 29.7%	14 21.9%
Grade 3 Diarrhoea, Across doses	1 1.6%	0 0%	1 1.6%
Related Diarrhoea, Across doses	5 8.1%	4 6.3%	2 3.1%
Grade 3 Related Diarrhoea, Across doses	0 0%	0 0%	0 0%
Medically Attended Diarrhoea, Across doses	2 3.2%	0 0%	0 0%
Any Fatigue, Across doses	43 69.4%	38 59.4%	20 31.3%
Grade 3 Fatigue, Across doses	8 12.9%	4 6.3%	3 4.7%
Related Fatigue, Across doses	24 38.7%	24 37.5%	9 14.1%
Grade 3 Related Fatigue, Across doses	3 4.8%	2 3.1%	1 1.6%
Medically Attended Fatigue, Across doses	1 1.6%	1 1.6%	0 0%
Any Headache, Across doses	32 51.6%	33 51.6%	21 32.8%
Grade 3 Headache, Across doses	4 6.5%	4 6.3%	1 1.6%
Related Headache, Across doses	15 24.2%	17 26.6%	11 17.2%
Grade 3 Related Headache, Across doses	3 4.8%	2 3.1%	0 0%
Medically Attended Headache, Across doses	2 3.2%	2 3.1%	1 1.6%
Any Myalgia, Across doses	33 53.2%	32 50%	12 18.8%
Grade 3 Myalgia, Across doses	4 6.5%	5 7.8%	1 1.6%
Related Myalgia, Across doses	22 35.5%	21 32.8%	4 6.3%
Grade 3 Related Myalgia, Across doses	2 3.2%	4 6.3%	0 0%
Medically Attended Myalgia, Across doses	0 0%	2 3.1%	1 1.6%
Any Nausea, Across doses	17 27.4%	14 21.9%	8 12.5%
Grade 3 Nausea, Across doses	1 1.6%	0 0%	0 0%
Related Nausea, Across doses	7 11.3%	4 6.3%	2 3.1%
Grade 3 Related Nausea, Across doses	0 0%	0 0%	0 0%
Medically Attended Nausea, Across doses	1 1.6%	0 0%	0 0%
Any Sweating, Across doses	11 17.7%	20 31.3%	10 15.6%
Grade 3 Sweating, Across doses	1 1.6%	2 3.1%	0 0%
Related Sweating, Across doses	6 9.7%	7 10.9%	1 1.6%
Grade 3 Related Sweating, Across doses	1 1.6%	1 1.6%	0 0%
Medically Attended Sweating, Across doses	0 0%	1 1.6%	0 0%
Any Temperature, Across doses	14 22.6%	9 14.1%	6 9.4%
Grade 3 Temperature, Across doses	2 3.2%	0 0%	0 0%
Related Temperature, Across doses	9 14.5%	4 6.3%	0 0%
Grade 3 Related Temperature, Across doses	1 1.6%	0 0%	0 0%
Medically Attended Temperature, Across doses	1 1.6%	1 1.6%	1 1.6%
Any Vomiting, Across doses	3 4.8%	2 3.1%	3 4.7%
Grade 3 Vomiting, Across doses	0 0%	0 0%	0 0%
Related Vomiting, Across doses	2 3.2%	0 0%	0 0%
Grade 3 Related Vomiting, Across doses	0 0%	0 0%	0 0%
Medically Attended Vomiting, Across doses	0 0%	0 0%	0 0%

11. Primary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 1 and Dose 2 vaccinations.
Time Frame	During the 28-Day (Days 0-27) period following Dose 1 and Dose 2

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and 2 vaccinations were identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	126	64
Any AE(s)	58 93.5%	29 45.3%
Grade 3 AE(s)	9 14.5%	3 4.7%
Related AE(s)	6 9.7%	2 3.1%
Grade 3 Related AE(s)	1 1.6%	0 0%
Medically Attended AE(s)	17 27.4%	13 20.3%

12. Primary Outcome

Title	Number of Subjects With Unsolicited AEs
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 3 and across doses.
Time Frame	During the 28-Day (Days 0-27) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	56	60	56
Any AE(s)	30 48.4%	42 65.6%	34 53.1%
Grade 3 AE(s)	3 4.8%	7 10.9%	3 4.7%
Related AE(s)	2 3.2%	6 9.4%	2 3.1%
Grade 3 Related AE(s)	0 0%	1 1.6%	0 0%
Medically Attended AE(s)	11 17.7%	14 21.9%	15 23.4%

13. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the entire study period (up to Week 48)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	62	64	64
Count of Participants [Participants]	1 1.6%	3 4.7%	2 3.1%

14. Primary Outcome

Title	Number of Subjects With Potentially Immune-Mediated Diseases (pIMDs)
Description	Potentially Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time Frame	During the entire study period (up to Week 48)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	62	64	64
Count of Participants [Participants]	0 0%	1 1.6%	0 0%

15. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Screening

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since the screening timepoint was identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	126	64
ALT, Grade 0	115 185.5%	63 98.4%
ALT, Grade 1	9 14.5%	1 1.6%
ALT, Grade 2	2 3.2%	0 0%
ALT, Grade 3	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%
ALB, Grade 0	126 203.2%	64 100%
ALB, Grade 1	0 0%	0 0%
ALB, Grade 2	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%
ALP, Grade 0	125 201.6%	64 100%
ALP, Grade 1	1 1.6%	0 0%
ALP, Grade 2	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%
AST, Grade 0	120 193.5%	63 98.4%
AST, Grade 1	6 9.7%	1 1.6%
AST, Grade 2	0 0%	0 0%
AST, Grade 3	0 0%	0 0%
AST, Grade 4	0 0%	0 0%
BIL, Grade 0	123 198.4%	63 98.4%
BIL, Grade 1	2 3.2%	0 0%
BIL, Grade 2	1 1.6%	1 1.6%
BIL, Grade 3	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%
CRE, Grade 0	124 200%	62 96.9%
CRE, Grade 1	2 3.2%	1 1.6%
CRE, Grade 2	0 0%	1 1.6%
CRE, Grade 3	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%
EOS, Grade 0	124 200%	64 100%
EOS, Grade 1	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%
EOS/100LEU, Grade 0	124 200%	64 100%
EOS/100LEU, Grade 1	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%
BIC, Grade 0	118 190.3%	59 92.2%
BIC, Grade 1	8 12.9%	5 7.8%
BIC, Grade 2	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%
HGB, Grade 0	126 203.2%	64 100%
HGB, Grade 1	0 0%	0 0%
HGB, Grade 2	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%
PTS, Grade 0	126 203.2%	64 100%
PTS, Grade 1	0 0%	0 0%
PTS, Grade 2	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%
LYM, Grade 0	124 200%	64 100%
LYM, Grade 1	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%
LYM/100LEU, Grade 0	124 200%	64 100%
LYM/100LEU, Grade 1	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%
SDI, Grade 0	115 185.5%	63 98.4%
SDI, Grade 1	11 17.7%	1 1.6%
SDI, Grade 2	0 0%	0 0%
SDI, Grade 3	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%
NEU, Grade 0	119 191.9%	64 100%
NEU, Grade 1	3 4.8%	0 0%
NEU, Grade 2	2 3.2%	0 0%
NEU, Grade 3	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%
NEU/100LEU, Grade 0	124 200%	64 100%
NEU/100LEU, Grade 1	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%
PLC, Grade 0	122 196.8%	63 98.4%
PLC, Grade 1	2 3.2%	0 0%
PLC, Grade 2	0 0%	1 1.6%
PLC, Grade 3	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%
PTT, Grade 0	116 187.1%	59 92.2%
PTT, Grade 1	10 16.1%	4 6.3%
PTT, Grade 2	0 0%	0 0%
PTT, Grade 3	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%
WBC, Grade 0	126 203.2%	64 100%
WBC, Grade 1	0 0%	0 0%
WBC, Grade 2	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%

16. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	Pre-vaccination, at Week 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	126	64
ALT, Grade 0	117 188.7%	62 96.9%
ALT, Grade 1	6 9.7%	2 3.1%
ALT, Grade 2	3 4.8%	0 0%
ALT, Grade 3	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%
ALB, Grade 0	125 201.6%	64 100%
ALB, Grade 1	1 1.6%	0 0%
ALB, Grade 2	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%
ALP, Grade 0	125 201.6%	64 100%
ALP, Grade 1	1 1.6%	0 0%
ALP, Grade 2	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%
AST, Grade 0	121 195.2%	61 95.3%
AST, Grade 1	3 4.8%	3 4.7%
AST, Grade 2	2 3.2%	0 0%
AST, Grade 3	0 0%	0 0%
AST, Grade 4	0 0%	0 0%
BIL, Grade 0	125 201.6%	63 98.4%
BIL, Grade 1	1 1.6%	0 0%
BIL, Grade 2	0 0%	1 1.6%
BIL, Grade 3	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%
CRE, Grade 0	125 201.6%	61 95.3%
CRE, Grade 1	0 0%	3 4.7%
CRE, Grade 2	1 1.6%	0 0%
CRE, Grade 3	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%
EOS, Grade 0	126 203.2%	64 100%
EOS, Grade 1	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%
EOS/100LEU, Grade 0	126 203.2%	64 100%
EOS/100LEU, Grade 1	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%
BIC, Grade 0	100 161.3%	47 73.4%
BIC, Grade 1	26 41.9%	17 26.6%
BIC, Grade 2	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%
HGB, Grade 0	126 203.2%	64 100%
HGB, Grade 1	0 0%	0 0%
HGB, Grade 2	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%
PTS, Grade 0	126 203.2%	64 100%
PTS, Grade 1	0 0%	0 0%
PTS, Grade 2	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%
LYM, Grade 0	126 203.2%	64 100%
LYM, Grade 1	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%
LYM/100LEU, Grade 0	126 203.2%	64 100%
LYM/100LEU, Grade 1	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%
SDI, Grade 0	114 183.9%	59 92.2%
SDI, Grade 1	11 17.7%	5 7.8%
SDI, Grade 2	1 1.6%	0 0%
SDI, Grade 3	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%
NEU, Grade 0	123 198.4%	62 96.9%
NEU, Grade 1	2 3.2%	0 0%
NEU, Grade 2	1 1.6%	2 3.1%
NEU, Grade 3	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%
NEU/100LEU, Grade 0	126 203.2%	64 100%
NEU/100LEU, Grade 1	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%
PLC, Grade 0	121 195.2%	63 98.4%
PLC, Grade 1	5 8.1%	0 0%
PLC, Grade 2	0 0%	1 1.6%
PLC, Grade 3	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%
PTT, Grade 0	118 190.3%	55 85.9%
PTT, Grade 1	7 11.3%	9 14.1%
PTT, Grade 2	1 1.6%	0 0%
PTT, Grade 3	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%
WBC, Grade 0	125 201.6%	63 98.4%
WBC, Grade 1	0 0%	0 0%
WBC, Grade 2	1 1.6%	1 1.6%
WBC, Grade 3	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%

17. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Week 4

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	126	64
ALT, Grade 0	114 183.9%	62 96.9%
ALT, Grade 1	10 16.1%	0 0%
ALT, Grade 2	2 3.2%	1 1.6%
ALT, Grade 3	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%
ALB, Grade 0	125 201.6%	63 98.4%
ALB, Grade 1	1 1.6%	0 0%
ALB, Grade 2	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%
ALP, Grade 0	124 200%	63 98.4%
ALP, Grade 1	2 3.2%	0 0%
ALP, Grade 2	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%
AST, Grade 0	119 191.9%	61 95.3%
AST, Grade 1	5 8.1%	2 3.1%
AST, Grade 2	2 3.2%	0 0%
AST, Grade 3	0 0%	0 0%
AST, Grade 4	0 0%	0 0%
BIL, Grade 0	125 201.6%	63 98.4%
BIL, Grade 1	1 1.6%	0 0%
BIL, Grade 2	0 0%	0 0%
BIL, Grade 3	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%
CRE, Grade 0	121 195.2%	61 95.3%
CRE, Grade 1	5 8.1%	2 3.1%
CRE, Grade 2	0 0%	0 0%
CRE, Grade 3	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%
EOS, Grade 0	126 203.2%	63 98.4%
EOS, Grade 1	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%
EOS/100LEU, Grade 0	126 203.2%	63 98.4%
EOS/100LEU, Grade 1	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%
BIC, Grade 0	99 159.7%	48 75%
BIC, Grade 1	27 43.5%	15 23.4%
BIC, Grade 2	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%
HGB, Grade 0	126 203.2%	63 98.4%
HGB, Grade 1	0 0%	0 0%
HGB, Grade 2	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%
PTS, Grade 0	124 200%	63 98.4%
PTS, Grade 1	2 3.2%	0 0%
PTS, Grade 2	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%
LYM, Grade 0	126 203.2%	63 98.4%
LYM, Grade 1	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%
LYM/100LEU, Grade 0	126 203.2%	63 98.4%
LYM/100LEU, Grade 1	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%
SDI, Grade 0	119 191.9%	60 93.8%
SDI, Grade 1	7 11.3%	3 4.7%
SDI, Grade 2	0 0%	0 0%
SDI, Grade 3	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%
NEU, Grade 0	122 196.8%	62 96.9%
NEU, Grade 1	4 6.5%	1 1.6%
NEU, Grade 2	0 0%	0 0%
NEU, Grade 3	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%
NEU/100LEU, Grade 0	126 203.2%	63 98.4%
NEU/100LEU, Grade 1	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%
PLC, Grade 0	123 198.4%	62 96.9%
PLC, Grade 1	2 3.2%	0 0%
PLC, Grade 2	1 1.6%	1 1.6%
PLC, Grade 3	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%
PTT, Grade 0	115 185.5%	54 84.4%
PTT, Grade 1	11 17.7%	9 14.1%
PTT, Grade 2	0 0%	0 0%
PTT, Grade 3	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%
WBC, Grade 0	126 203.2%	63 98.4%
WBC, Grade 1	0 0%	0 0%
WBC, Grade 2	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%

18. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Week 6

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	126	64
ALT, Grade 0	117 188.7%	60 93.8%
ALT, Grade 1	5 8.1%	2 3.1%
ALT, Grade 2	3 4.8%	0 0%
ALT, Grade 3	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%
ALB, Grade 0	124 200%	62 96.9%
ALB, Grade 1	1 1.6%	0 0%
ALB, Grade 2	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%
ALP, Grade 0	123 198.4%	62 96.9%
ALP, Grade 1	2 3.2%	0 0%
ALP, Grade 2	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%
AST, Grade 0	118 190.3%	61 95.3%
AST, Grade 1	6 9.7%	1 1.6%
AST, Grade 2	1 1.6%	0 0%
AST, Grade 3	0 0%	0 0%
AST, Grade 4	0 0%	0 0%
BIL, Grade 0	121 195.2%	62 96.9%
BIL, Grade 1	4 6.5%	0 0%
BIL, Grade 2	0 0%	0 0%
BIL, Grade 3	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%
CRE, Grade 0	119 191.9%	60 93.8%
CRE, Grade 1	6 9.7%	2 3.1%
CRE, Grade 2	0 0%	0 0%
CRE, Grade 3	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%
EOS, Grade 0	125 201.6%	62 96.9%
EOS, Grade 1	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%
EOS/100LEU, Grade 0	125 201.6%	62 96.9%
EOS/100LEU, Grade 1	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%
BIC, Grade 0	92 148.4%	39 60.9%
BIC, Grade 1	33 53.2%	23 35.9%
BIC, Grade 2	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%
HGB, Grade 0	125 201.6%	62 96.9%
HGB, Grade 1	0 0%	0 0%
HGB, Grade 2	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%
PTS, Grade 0	124 200%	60 93.8%
PTS, Grade 1	1 1.6%	2 3.1%
PTS, Grade 2	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%
LYM, Grade 0	125 201.6%	62 96.9%
LYM, Grade 1	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%
LYM/100LEU, Grade 0	125 201.6%	62 96.9%
LYM/100LEU, Grade 1	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%
SDI, Grade 0	117 188.7%	58 90.6%
SDI, Grade 1	7 11.3%	4 6.3%
SDI, Grade 2	1 1.6%	0 0%
SDI, Grade 3	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%
NEU, Grade 0	121 195.2%	62 96.9%
NEU, Grade 1	3 4.8%	0 0%
NEU, Grade 2	1 1.6%	0 0%
NEU, Grade 3	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%
NEU/100LEU, Grade 0	125 201.6%	62 96.9%
NEU/100LEU, Grade 1	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%
PLC, Grade 0	122 196.8%	61 95.3%
PLC, Grade 1	3 4.8%	0 0%
PLC, Grade 2	0 0%	0 0%
PLC, Grade 3	0 0%	1 1.6%
PLC, Grade 4	0 0%	0 0%
PTT, Grade 0	118 190.3%	51 79.7%
PTT, Grade 1	7 11.3%	11 17.2%
PTT, Grade 2	0 0%	0 0%
PTT, Grade 3	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%
WBC, Grade 0	125 201.6%	62 96.9%
WBC, Grade 1	0 0%	0 0%
WBC, Grade 2	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%

19. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	126	64
ALT, Grade 0	113 182.3%	60 93.8%
ALT, Grade 1	10 16.1%	0 0%
ALT, Grade 2	1 1.6%	1 1.6%
ALT, Grade 3	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%
ALB, Grade 0	123 198.4%	61 95.3%
ALB, Grade 1	1 1.6%	0 0%
ALB, Grade 2	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%
ALP, Grade 0	122 196.8%	61 95.3%
ALP, Grade 1	2 3.2%	0 0%
ALP, Grade 2	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%
AST, Grade 0	117 188.7%	59 92.2%
AST, Grade 1	6 9.7%	2 3.1%
AST, Grade 2	1 1.6%	0 0%
AST, Grade 3	0 0%	0 0%
AST, Grade 4	0 0%	0 0%
BIL, Grade 0	124 200%	59 92.2%
BIL, Grade 1	0 0%	1 1.6%
BIL, Grade 2	0 0%	1 1.6%
BIL, Grade 3	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%
CRE, Grade 0	119 191.9%	60 93.8%
CRE, Grade 1	5 8.1%	1 1.6%
CRE, Grade 2	0 0%	0 0%
CRE, Grade 3	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%
EOS, Grade 0	124 200%	61 95.3%
EOS, Grade 1	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%
EOS/100LEU, Grade 0	124 200%	61 95.3%
EOS/100LEU, Grade 1	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%
BIC, Grade 0	93 150%	47 73.4%
BIC, Grade 1	31 50%	14 21.9%
BIC, Grade 2	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%
HGB, Grade 0	122 196.8%	61 95.3%
HGB, Grade 1	2 3.2%	0 0%
HGB, Grade 2	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%
PTS, Grade 0	123 198.4%	61 95.3%
PTS, Grade 1	1 1.6%	0 0%
PTS, Grade 2	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%
LYM, Grade 0	124 200%	61 95.3%
LYM, Grade 1	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%
LYM/100LEU, Grade 0	124 200%	61 95.3%
LYM/100LEU, Grade 1	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%
SDI, Grade 0	121 195.2%	58 90.6%
SDI, Grade 1	3 4.8%	3 4.7%
SDI, Grade 2	0 0%	0 0%
SDI, Grade 3	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%
NEU, Grade 0	121 195.2%	60 93.8%
NEU, Grade 1	2 3.2%	1 1.6%
NEU, Grade 2	1 1.6%	0 0%
NEU, Grade 3	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%
NEU/100LEU, Grade 0	124 200%	61 95.3%
NEU/100LEU, Grade 1	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%
PLC, Grade 0	119 191.9%	60 93.8%
PLC, Grade 1	4 6.5%	1 1.6%
PLC, Grade 2	1 1.6%	0 0%
PLC, Grade 3	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%
PTT, Grade 0	111 179%	55 85.9%
PTT, Grade 1	13 21%	6 9.4%
PTT, Grade 2	0 0%	0 0%
PTT, Grade 3	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%
WBC, Grade 0	124 200%	61 95.3%
WBC, Grade 1	0 0%	0 0%
WBC, Grade 2	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%

20. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Week 28

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.

Arm/Group Title	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	126	64
ALT, Grade 0	112 180.6%	57 89.1%
ALT, Grade 1	5 8.1%	2 3.1%
ALT, Grade 2	3 4.8%	1 1.6%
ALT, Grade 3	0 0%	0 0%
ALT, Grade 4	1 1.6%	0 0%
ALB, Grade 0	121 195.2%	60 93.8%
ALB, Grade 1	0 0%	0 0%
ALB, Grade 2	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%
ALP, Grade 0	121 195.2%	60 93.8%
ALP, Grade 1	0 0%	0 0%
ALP, Grade 2	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%
AST, Grade 0	115 185.5%	57 89.1%
AST, Grade 1	4 6.5%	3 4.7%
AST, Grade 2	1 1.6%	0 0%
AST, Grade 3	0 0%	0 0%
AST, Grade 4	1 1.6%	0 0%
BIL, Grade 0	119 191.9%	59 92.2%
BIL, Grade 1	1 1.6%	0 0%
BIL, Grade 2	1 1.6%	1 1.6%
BIL, Grade 3	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%
CRE, Grade 0	119 191.9%	59 92.2%
CRE, Grade 1	2 3.2%	0 0%
CRE, Grade 2	0 0%	1 1.6%
CRE, Grade 3	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%
EOS, Grade 0	121 195.2%	60 93.8%
EOS, Grade 1	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%
EOS/100LEU, Grade 0	121 195.2%	60 93.8%
EOS/100LEU, Grade 1	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%
BIC, Grade 0	92 148.4%	45 70.3%
BIC, Grade 1	29 46.8%	15 23.4%
BIC, Grade 2	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%
HGB, Grade 0	120 193.5%	59 92.2%
HGB, Grade 1	1 1.6%	1 1.6%
HGB, Grade 2	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%
PTS, Grade 0	120 193.5%	60 93.8%
PTS, Grade 1	1 1.6%	0 0%
PTS, Grade 2	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%
LYM, Grade 0	121 195.2%	60 93.8%
LYM, Grade 1	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%
LYM/100LEU, Grade 0	121 195.2%	60 93.8%
LYM/100LEU, Grade 1	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%
SDI, Grade 0	115 185.5%	57 89.1%
SDI, Grade 1	6 9.7%	3 4.7%
SDI, Grade 2	0 0%	0 0%
SDI, Grade 3	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%
NEU, Grade 0	115 185.5%	58 90.6%
NEU, Grade 1	3 4.8%	2 3.1%
NEU, Grade 2	3 4.8%	0 0%
NEU, Grade 3	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%
NEU/100LEU, Grade 0	121 195.2%	60 93.8%
NEU/100LEU, Grade 1	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%
PLC, Grade 0	118 190.3%	59 92.2%
PLC, Grade 1	2 3.2%	0 0%
PLC, Grade 2	1 1.6%	1 1.6%
PLC, Grade 3	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%
PTT, Grade 0	110 177.4%	54 84.4%
PTT, Grade 1	11 17.7%	6 9.4%
PTT, Grade 2	0 0%	0 0%
PTT, Grade 3	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%
WBC, Grade 0	121 195.2%	60 93.8%
WBC, Grade 1	0 0%	0 0%
WBC, Grade 2	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%

21. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Week 30

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Arm/Group Title	Control Group	3D_HIV Group	2D_HIV Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	64	62	64
ALT, Grade 0	53 85.5%	54 84.4%	57 89.1%
ALT, Grade 1	5 8.1%	2 3.1%	1 1.6%
ALT, Grade 2	0 0%	1 1.6%	1 1.6%
ALT, Grade 3	0 0%	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%	1 1.6%
ALB, Grade 0	57 91.9%	57 89.1%	60 93.8%
ALB, Grade 1	1 1.6%	0 0%	0 0%
ALB, Grade 2	0 0%	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%	0 0%
ALP, Grade 0	58 93.5%	56 87.5%	60 93.8%
ALP, Grade 1	0 0%	1 1.6%	0 0%
ALP, Grade 2	0 0%	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%	0 0%
AST, Grade 0	55 88.7%	54 84.4%	58 90.6%
AST, Grade 1	3 4.8%	3 4.7%	1 1.6%
AST, Grade 2	0 0%	0 0%	0 0%
AST, Grade 3	0 0%	0 0%	1 1.6%
AST, Grade 4	0 0%	0 0%	0 0%
BIL, Grade 0	55 88.7%	57 89.1%	59 92.2%
BIL, Grade 1	3 4.8%	0 0%	1 1.6%
BIL, Grade 2	0 0%	0 0%	0 0%
BIL, Grade 3	0 0%	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%	0 0%
CRE, Grade 0	57 91.9%	55 85.9%	59 92.2%
CRE, Grade 1	1 1.6%	2 3.1%	1 1.6%
CRE, Grade 2	0 0%	0 0%	0 0%
CRE, Grade 3	0 0%	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%	0 0%
EOS, Grade 0	58 93.5%	57 89.1%	60 93.8%
EOS, Grade 1	0 0%	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%	0 0%
EOS/100LEU, Grade 0	58 93.5%	57 89.1%	60 93.8%
EOS/100LEU, Grade 1	0 0%	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%	0 0%
BIC, Grade 0	43 69.4%	45 70.3%	45 70.3%
BIC, Grade 1	15 24.2%	12 18.8%	15 23.4%
BIC, Grade 2	0 0%	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%	0 0%
HGB, Grade 0	57 91.9%	56 87.5%	60 93.8%
HGB, Grade 1	0 0%	1 1.6%	0 0%
HGB, Grade 2	0 0%	0 0%	0 0%
HGB, Grade 3	1 1.6%	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%	0 0%
PTS, Grade 0	58 93.5%	56 87.5%	60 93.8%
PTS, Grade 1	0 0%	1 1.6%	0 0%
PTS, Grade 2	0 0%	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%	0 0%
LYM, Grade 0	58 93.5%	57 89.1%	60 93.8%
LYM, Grade 1	0 0%	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%	0 0%
LYM/100LEU, Grade 0	58 93.5%	57 89.1%	60 93.8%
LYM/100LEU, Grade 1	0 0%	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%	0 0%
SDI, Grade 0	51 82.3%	55 85.9%	59 92.2%
SDI, Grade 1	7 11.3%	2 3.1%	1 1.6%
SDI, Grade 2	0 0%	0 0%	0 0%
SDI, Grade 3	0 0%	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%	0 0%
NEU, Grade 0	55 88.7%	53 82.8%	58 90.6%
NEU, Grade 1	3 4.8%	4 6.3%	2 3.1%
NEU, Grade 2	0 0%	0 0%	0 0%
NEU, Grade 3	0 0%	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%	0 0%
NEU/100LEU, Grade 0	58 93.5%	57 89.1%	60 93.8%
NEU/100LEU, Grade 1	0 0%	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%	0 0%
PLC, Grade 0	58 93.5%	56 87.5%	59 92.2%
PLC, Grade 1	0 0%	1 1.6%	0 0%
PLC, Grade 2	0 0%	0 0%	1 1.6%
PLC, Grade 3	0 0%	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%	0 0%
PTT, Grade 0	53 85.5%	51 79.7%	56 87.5%
PTT, Grade 1	5 8.1%	6 9.4%	4 6.3%
PTT, Grade 2	0 0%	0 0%	0 0%
PTT, Grade 3	0 0%	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%	0 0%
WBC, Grade 0	58 93.5%	57 89.1%	60 93.8%
WBC, Grade 1	0 0%	0 0%	0 0%
WBC, Grade 2	0 0%	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%	0 0%

22. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Week 38

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Arm/Group Title	Control Group	3D_HIV Group	2D_HIV Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	64	62	64
ALT, Grade 0	53 85.5%	52 81.3%	61 95.3%
ALT, Grade 1	4 6.5%	3 4.7%	1 1.6%
ALT, Grade 2	0 0%	2 3.1%	1 1.6%
ALT, Grade 3	1 1.6%	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%	0 0%
ALB, Grade 0	57 91.9%	57 89.1%	63 98.4%
ALB, Grade 1	0 0%	0 0%	0 0%
ALB, Grade 2	1 1.6%	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%	0 0%
ALP, Grade 0	58 93.5%	55 85.9%	63 98.4%
ALP, Grade 1	0 0%	2 3.1%	0 0%
ALP, Grade 2	0 0%	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%	0 0%
AST, Grade 0	55 88.7%	52 81.3%	61 95.3%
AST, Grade 1	2 3.2%	4 6.3%	2 3.1%
AST, Grade 2	1 1.6%	1 1.6%	0 0%
AST, Grade 3	0 0%	0 0%	0 0%
AST, Grade 4	0 0%	0 0%	0 0%
BIL, Grade 0	56 90.3%	57 89.1%	61 95.3%
BIL, Grade 1	1 1.6%	0 0%	1 1.6%
BIL, Grade 2	1 1.6%	0 0%	1 1.6%
BIL, Grade 3	0 0%	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%	0 0%
CRE, Grade 0	56 90.3%	54 84.4%	61 95.3%
CRE, Grade 1	2 3.2%	3 4.7%	2 3.1%
CRE, Grade 2	0 0%	0 0%	0 0%
CRE, Grade 3	0 0%	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%	0 0%
EOS, Grade 0	58 93.5%	57 89.1%	63 98.4%
EOS, Grade 1	0 0%	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%	0 0%
EOS/100LEU, Grade 0	58 93.5%	57 89.1%	63 98.4%
EOS/100LEU, Grade 1	0 0%	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%	0 0%
BIC, Grade 0	46 74.2%	47 73.4%	51 79.7%
BIC, Grade 1	11 17.7%	10 15.6%	12 18.8%
BIC, Grade 2	1 1.6%	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%	0 0%
HGB, Grade 0	57 91.9%	56 87.5%	63 98.4%
HGB, Grade 1	0 0%	1 1.6%	0 0%
HGB, Grade 2	0 0%	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%	0 0%
HGB, Grade 4	1 1.6%	0 0%	0 0%
PTS, Grade 0	57 91.9%	57 89.1%	61 95.3%
PTS, Grade 1	1 1.6%	0 0%	2 3.1%
PTS, Grade 2	0 0%	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%	0 0%
LYM, Grade 0	58 93.5%	57 89.1%	63 98.4%
LYM, Grade 1	0 0%	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%	0 0%
LYM/100LEU, Grade 0	58 93.5%	57 89.1%	63 98.4%
LYM/100LEU, Grade 1	0 0%	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%	0 0%
SDI, Grade 0	54 87.1%	54 84.4%	61 95.3%
SDI, Grade 1	4 6.5%	3 4.7%	2 3.1%
SDI, Grade 2	0 0%	0 0%	0 0%
SDI, Grade 3	0 0%	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%	0 0%
NEU, Grade 0	56 90.3%	54 84.4%	59 92.2%
NEU, Grade 1	2 3.2%	2 3.1%	3 4.7%
NEU, Grade 2	0 0%	1 1.6%	1 1.6%
NEU, Grade 3	0 0%	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%	0 0%
NEU/100LEU, Grade 0	58 93.5%	57 89.1%	63 98.4%
NEU/100LEU, Grade 1	0 0%	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%	0 0%
PLC, Grade 0	58 93.5%	55 85.9%	59 92.2%
PLC, Grade 1	0 0%	2 3.1%	3 4.7%
PLC, Grade 2	0 0%	0 0%	1 1.6%
PLC, Grade 3	0 0%	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%	0 0%
PTT, Grade 0	51 82.3%	52 81.3%	55 85.9%
PTT, Grade 1	7 11.3%	5 7.8%	7 10.9%
PTT, Grade 2	0 0%	0 0%	0 0%
PTT, Grade 3	0 0%	0 0%	1 1.6%
PTT, Grade 4	0 0%	0 0%	0 0%
WBC, Grade 0	58 93.5%	56 87.5%	63 98.4%
WBC, Grade 1	0 0%	1 1.6%	0 0%
WBC, Grade 2	0 0%	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%	0 0%

23. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Values
Description	Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).
Time Frame	At Week 48

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.

Arm/Group Title	Control Group	3D_HIV Group	2D_HIV Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	64	62	64
ALT, Grade 0	52 83.9%	55 85.9%	61 95.3%
ALT, Grade 1	3 4.8%	1 1.6%	2 3.1%
ALT, Grade 2	2 3.2%	1 1.6%	0 0%
ALT, Grade 3	1 1.6%	0 0%	0 0%
ALT, Grade 4	0 0%	0 0%	0 0%
ALB, Grade 0	58 93.5%	56 87.5%	63 98.4%
ALB, Grade 1	0 0%	1 1.6%	0 0%
ALB, Grade 2	0 0%	0 0%	0 0%
ALB, Grade 3	0 0%	0 0%	0 0%
ALB, Grade 4	0 0%	0 0%	0 0%
ALP, Grade 0	57 91.9%	55 85.9%	63 98.4%
ALP, Grade 1	1 1.6%	2 3.1%	0 0%
ALP, Grade 2	0 0%	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%	0 0%
AST, Grade 0	54 87.1%	56 87.5%	63 98.4%
AST, Grade 1	2 3.2%	1 1.6%	0 0%
AST, Grade 2	2 3.2%	0 0%	0 0%
AST, Grade 3	0 0%	0 0%	0 0%
AST, Grade 4	0 0%	0 0%	0 0%
BIL, Grade 0	56 90.3%	57 89.1%	63 98.4%
BIL, Grade 1	1 1.6%	0 0%	0 0%
BIL, Grade 2	1 1.6%	0 0%	0 0%
BIL, Grade 3	0 0%	0 0%	0 0%
BIL, Grade 4	0 0%	0 0%	0 0%
CRE, Grade 0	55 88.7%	54 84.4%	62 96.9%
CRE, Grade 1	3 4.8%	3 4.7%	1 1.6%
CRE, Grade 2	0 0%	0 0%	0 0%
CRE, Grade 3	0 0%	0 0%	0 0%
CRE, Grade 4	0 0%	0 0%	0 0%
EOS, Grade 0	58 93.5%	57 89.1%	63 98.4%
EOS, Grade 1	0 0%	0 0%	0 0%
EOS, Grade 2	0 0%	0 0%	0 0%
EOS, Grade 3	0 0%	0 0%	0 0%
EOS, Grade 4	0 0%	0 0%	0 0%
EOS/100LEU, Grade 0	58 93.5%	57 89.1%	63 98.4%
EOS/100LEU, Grade 1	0 0%	0 0%	0 0%
EOS/100LEU, Grade 2	0 0%	0 0%	0 0%
EOS/100LEU, Grade 3	0 0%	0 0%	0 0%
EOS/100LEU, Grade 4	0 0%	0 0%	0 0%
BIC, Grade 0	49 79%	43 67.2%	51 79.7%
BIC, Grade 1	9 14.5%	14 21.9%	12 18.8%
BIC, Grade 2	0 0%	0 0%	0 0%
BIC, Grade 3	0 0%	0 0%	0 0%
BIC, Grade 4	0 0%	0 0%	0 0%
HGB, Grade 0	58 93.5%	56 87.5%	63 98.4%
HGB, Grade 1	0 0%	1 1.6%	0 0%
HGB, Grade 2	0 0%	0 0%	0 0%
HGB, Grade 3	0 0%	0 0%	0 0%
HGB, Grade 4	0 0%	0 0%	0 0%
PTS, Grade 0	58 93.5%	57 89.1%	61 95.3%
PTS, Grade 1	0 0%	0 0%	2 3.1%
PTS, Grade 2	0 0%	0 0%	0 0%
PTS, Grade 3	0 0%	0 0%	0 0%
PTS, Grade 4	0 0%	0 0%	0 0%
LYM, Grade 0	58 93.5%	57 89.1%	63 98.4%
LYM, Grade 1	0 0%	0 0%	0 0%
LYM, Grade 2	0 0%	0 0%	0 0%
LYM, Grade 3	0 0%	0 0%	0 0%
LYM, Grade 4	0 0%	0 0%	0 0%
LYM/100LEU, Grade 0	58 93.5%	57 89.1%	63 98.4%
LYM/100LEU, Grade 1	0 0%	0 0%	0 0%
LYM/100LEU, Grade 2	0 0%	0 0%	0 0%
LYM/100LEU, Grade 3	0 0%	0 0%	0 0%
LYM/100LEU, Grade 4	0 0%	0 0%	0 0%
SDI, Grade 0	55 88.7%	56 87.5%	58 90.6%
SDI, Grade 1	3 4.8%	1 1.6%	5 7.8%
SDI, Grade 2	0 0%	0 0%	0 0%
SDI, Grade 3	0 0%	0 0%	0 0%
SDI, Grade 4	0 0%	0 0%	0 0%
NEU, Grade 0	57 91.9%	53 82.8%	60 93.8%
NEU, Grade 1	0 0%	4 6.3%	3 4.7%
NEU, Grade 2	1 1.6%	0 0%	0 0%
NEU, Grade 3	0 0%	0 0%	0 0%
NEU, Grade 4	0 0%	0 0%	0 0%
NEU/100LEU, Grade 0	58 93.5%	57 89.1%	63 98.4%
NEU/100LEU, Grade 1	0 0%	0 0%	0 0%
NEU/100LEU, Grade 2	0 0%	0 0%	0 0%
NEU/100LEU, Grade 3	0 0%	0 0%	0 0%
NEU/100LEU, Grade 4	0 0%	0 0%	0 0%
PLC, Grade 0	58 93.5%	56 87.5%	62 96.9%
PLC, Grade 1	0 0%	0 0%	0 0%
PLC, Grade 2	0 0%	1 1.6%	1 1.6%
PLC, Grade 3	0 0%	0 0%	0 0%
PLC, Grade 4	0 0%	0 0%	0 0%
PTT, Grade 0	48 77.4%	55 85.9%	58 90.6%
PTT, Grade 1	8 12.9%	2 3.1%	5 7.8%
PTT, Grade 2	0 0%	0 0%	0 0%
PTT, Grade 3	2 3.2%	0 0%	0 0%
PTT, Grade 4	0 0%	0 0%	0 0%
WBC, Grade 0	58 93.5%	57 89.1%	63 98.4%
WBC, Grade 1	0 0%	0 0%	0 0%
WBC, Grade 2	0 0%	0 0%	0 0%
WBC, Grade 3	0 0%	0 0%	0 0%
WBC, Grade 4	0 0%	0 0%	0 0%

24. Secondary Outcome

Title	Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline
Description	Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/mL. Baseline of HIV-1 viral load was defined as the geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 28 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.
Time Frame	At Weeks 1, 4, 6, 16, 28, 30 and 38

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	HIV Group	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	124	53	58	60
HIV-1 VL, Week 1	1.0 (0.18)	0.9 (0.18)
HIV-1 VL, Week 4	1.1 (0.28)	1.1 (0.32)
HIV-1 VL, Week 6	1.1 (0.26)	1.2 (0.37)
HIV-1 VL, Week 16	1.1 (0.31)	1.1 (0.28)
HIV-1 VL, Week 28	1.2 (0.35)	1.2 (0.36)
HIV-1 VL, Week 30	1.1 (0.24)	1.2 (0.38)	1.2 (0.34)
HIV-1 VL, Week 38	0.9 (0.28)	1.2 (0.32)	1.2 (0.43)

25. Secondary Outcome

Title	Geometric Mean Change in HIV-1 VL From Baseline
Description	Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 29 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.
Time Frame	At Weeks 1, 4, 6, 16, 28, 30 and 38

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	HIV Group	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	124	53	58	60
HIV-1 VL, Week 1	0.0 (0.18)	-0.1 (0.18)
HIV-1 VL, Week 4	0.0 (0.28)	0.1 (0.32)
HIV-1 VL, Week 6	0.1 (0.26)	0.1 (0.37)
HIV-1 VL, Week 16	0.0 (0.31)	0.0 (0.28)
HIV-1 VL, Week 28	0.1 (0.35)	0.1 (0.36)
HIV-1 VL, Week 30	0.0 (0.24)	0.1 (0.38)	0.1 (0.34)
HIV-1 VL, Week 38	0.0 (0.28)	0.1 (0.32)	0.1 (0.43)

26. Secondary Outcome

Title	Levels of HIV-1 Viral Load (VL)
Description	HIV-1 VL, using crude values, was expressed in RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.
Time Frame	At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	HIV Group	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	125	53	58	60
HIV-1 VL, Screening	13797	12882.5
HIV-1 VL, Pre-vaccination	12982	12688.5
HIV-1 VL, Week 1	14939	11936
HIV-1 VL, Week 4	14242.5	11627.5
HIV-1 VL, Week 6	17019	15117.5
HIV-1 VL, Week 16	15045	14605
HIV-1 VL, Week 28	12552.5	13208
HIV-1 VL, Week 30	14703	13902	12855.5
HIV-1 VL, Week 38	12248	14739	12264.5
HIV-1 VL, Week 48	11004.5	18415	15266.5

27. Secondary Outcome

Title	Levels of HIV-1 VL
Description	HIV-1 VL, using log10 transformed values, was expressed in log10-RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.
Time Frame	At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	HIV Group	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	125	53	58	60
HIV-1 VL, Screening	4.14	4.11
HIV-1 VL, Pre-vaccination	4.113	4.103
HIV-1 VL, Week 1	4.174	4.077
HIV-1 VL, Week 4	4.153	4.065
HIV-1 VL, Week 6	4.231	4.179
HIV-1 VL, Week 16	4.177	4.163
HIV-1 VL, Week 28	4.099	4.12
HIV-1 VL, Week 30	4.167	4.143	4.108
HIV-1 VL, Week 38	4.088	4.168	4.089
HIV-1 VL, Week 48	4.04	4.265	4.184

28. Secondary Outcome

Title	Percentage of Subjects With Plasmatic HIV-1 Viral Load Decrease Higher Than (>) 1
Description	The proportion of subjects with >1 decrease of HIV-1 VL, was determined using log10-transformed values.
Time Frame	At Week 48

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	46	55	50
Number [Percentage of participants]	0.00 0%	0.00 0%	0.00 0%

29. Secondary Outcome

Title	Cluster of Differentiation 4 (CD4) Absolute Cell Count
Description	Result determination, using crude values, was done from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening (SCR) to Week (W) 48 for the Control Group.
Time Frame	At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	HIV Group	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	125	53	58	60
CD4, Screening	677.072 (164.31)	688.2 (141.74)
CD4, Pre-vaccination	687.566 (184.41)	712.407 (251.98)
CD4, Week 1	723.91 (228.73)	711.905 (226.84)
CD4, Week 4	676.992 (182.96)	688.717 (186.24)
CD4, Week 6	691.174 (195.35)	687.883 (202.79)
CD4, Week 16	674.215 (213.69)	674.75 (186.63)
CD4, Week 28	630.836 (172.16)	667.981 (183.53)
CD4, Week 30	649.377 (193.66)	654.448 (202.71)	662.481 (181.76)
CD4, Week 38	660.306 (202.04)	635.561 (174.15)	653.154 (176.71)
CD4, Week 48	636.957 (175.72)	650.418 (206.12)	601.9 (186.81)

30. Secondary Outcome

Title	Mean Change in CD4 Cell Count From Baseline
Description	Baseline for CD4 cell count analysis was defined as the mean of values measured in blood taken at Screening and at pre vaccination (PRE). Result determination, using crude values, was done from week 1 to 28 for the HIV Group, weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from week 1 to week 48 for the Control Group.
Time Frame	At Weeks 1, 4, 6, 16, 28, 30, 38 and 48

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	HIV Group	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	124	53	58	60
CD4, Week 1	4.633 (16.53)	0.589 (17.98)
CD4, Week 4	-0.201 (17.97)	-1.212 (18.58)
CD4, Week 6	2.066 (19.97)	-1.713 (19.68)
CD4, Week 16	-0.52 (20.82)	-2.568 (19.68)
CD4, Week 28	-5.782 (19.13)	-4.421 (16.06)
CD4, Week 30	-5.641 (19.17)	-2.417 (20.31)	-4.403 (19.88)
CD4, Week 38	-4.224 (22.97)	-4.626 (20.01)	-5.936 (16.85)
CD4, Week 48	-9.859 (18.66)	-3.915 (19.56)	-13.82 (18.67)

31. Secondary Outcome

Title	Percentage of Subjects With ART (Anti-Retroviral Therapy) Initiation and HIV-related Clinical Events
Description	Only actual ART initiations were reported under the category "ART initiation". HIV-related clinical events were defined as: clinical disease progression, or confirmed VL > 100.000 copies/mL, or confirmed CD4 cell count < 350 cells/ cubic millimeter (mm3).
Time Frame	During the entire study period (up to Week 48)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.

Arm/Group Title	3D_HIV Group	2D_HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	61	64	60
ART initiation	8.2 13.2%	6.3 9.8%	8.3 13%
HIV related clinical events	9.8 15.8%	10.9 17%	10.0 15.6%

32. Secondary Outcome

Title	Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)
Description	Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2), as assessed by Intracellular Cytokine Staining (ICS).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
F4co-Computed, Pre-vaccination	430.0	469.0	435.0	364.0
F4co-Computed, Week 6	2559.5	1686.0	2014.5	557.5
F4co-Computed, Week 28	818.0	677.5	751.0	345.0
F4co-Computed, Week 30	2495.5	681.0	521.0
F4co-Computed, Week 48	937.0	534.5	365.0
Nef, Pre-vaccination	43.0	42.0	43.0	46.0
Nef, Week 6	521.0	219.0	259.0	45.5
Nef, Week 28	157.0	97.5	122.0	29.0
Nef, Week 30	672.0	104.0	42.0
Nef, Week 48	166.0	96.0	26.0
p17, Pre-vaccination	111.5	92.0	97.0	105.0
p17, Week 6	226.0	226.0	226.0	130.5
p17, Week 28	132.0	109.5	118.0	68.0
p17, Week 30	173.5	115.0	106.5
p17, Week 48	100.0	120.0	78.5
p24, Pre-vaccination	140.5	121.0	127.0	129.0
p24, Week 6	271.0	222.0	253.0	127.0
p24, Week 28	184.0	159.0	178.0	120.0
p24, Week 30	256.0	183.5	155.0
p24, Week 48	197.0	129.0	119.5
RT, Pre-vaccination	158.0	126.0	132.0	116.0
RT, Week 6	1160.0	837.0	1070.5	174.0
RT, Week 28	297.0	279.5	297.0	101.0
RT, Week 30	1155.0	245.5	180.5
RT, Week 48	365.5	170.0	120.0

33. Secondary Outcome

Title	Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine
Description	Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
F4co-Computed, Pre-vaccination	1135.5	997.0	1022.0	953.0
F4co-Computed, Week 6	3675.0	2506.5	2864.0	1243.0
F4co-Computed, Week 28	1587.0	1253.0	1433.0	786.0
F4co-Computed, Week 30	4039.0	1108.0	1157.0
F4co-Computed, Week 48	1947.0	1039.5	1251.0
Nef, Pre-vaccination	87.0	87.0	87.0	108.0
Nef, Week 6	599.0	392.0	434.0	115.0
Nef, Week 28	227.0	179.5	208.0	73.0
Nef, Week 30	763.0	204.0	113.0
Nef, Week 48	258.5	146.0	87.0
p17, Pre-vaccination	249.5	164.0	228.0	263.0
p17, Week 6	517.0	379.5	393.0	267.0
p17, Week 28	284.0	243.5	281.0	228.0
p17, Week 30	413.0	242.0	303.0
p17, Week 48	261.0	244.0	245.5
p24, Pre-vaccination	459.0	339.0	379.0	379.0
p24, Week 6	596.0	452.0	486.0	505.5
p24, Week 28	439.0	381.5	408.0	277.0
p24, Week 30	596.0	424.5	401.5
p24, Week 48	486.0	371.0	404.5
RT, Pre-vaccination	268.5	238.0	247.0	204.0
RT, Week 6	1588.5	1074.0	1346.0	296.0
RT, Week 28	378.0	379.0	378.0	204.0
RT, Week 30	1629.0	327.5	256.0
RT, Week 48	451.5	299.0	222.0

34. Secondary Outcome

Title	Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.
Description	Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L-CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L-CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
F4co-Computed, Pre-vaccination	874.0	973.0	945.0	1433.0
F4co-Computed, Week 6	1189.0	1086.5	1090.0	1227.0
F4co-Computed, Week 28	892.0	1115.5	986.0	1118.0
F4co-Computed, Week 30	1376.0	1198.0	1416.0
F4co-Computed, Week 48	1193.0	1006.5	1419.0
Nef, Pre-vaccination	148.0	239.0	195.0	263.0
Nef, Week 6	302.0	301.5	301.5	211.5
Nef, Week 28	169.0	261.5	241.0	197.0
Nef, Week 30	245.0	273.0	250.0
Nef, Week 48	215.0	174.0	267.5
p17, Pre-vaccination	204.5	184.0	188.0	230.0
p17, Week 6	229.0	231.5	230.0	293.5
p17, Week 28	164.0	238.0	210.0	203.0
p17, Week 30	279.5	166.0	229.0
p17, Week 48	210.0	177.0	224.5
p24, Pre-vaccination	297.5	287.0	294.0	377.0
p24, Week 6	287.0	344.5	288.0	428.5
p24, Week 28	296.0	340.0	313.0	487.0
p24, Week 30	389.0	298.0	492.5
p24, Week 48	341.0	369.0	396.5
RT, Pre-vaccination	175.5	194.0	194.0	235.0
RT, Week 6	369.0	258.5	304.0	144.0
RT, Week 28	210.0	118.0	148.0	138.0
RT, Week 30	369.0	162.0	162.0
RT, Week 48	270.5	132.5	158.0

35. Secondary Outcome

Title	Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine
Description	Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
F4co-Computed, Pre-vaccination	2360.5	1998.0	2068.0	2420.0
F4co-Computed, Week 6	5024.5	4146.5	4432.0	2711.5
F4co-Computed, Week 28	2885.0	2374.0	2459.0	2052.0
F4co-Computed, Week 30	5376.5	2538.0	2593.0
F4co-Computed, Week 48	3266.0	2544.5	2398.0
Nef, Pre-vaccination	284.5	390.0	337.0	386.0
Nef, Week 6	983.5	805.0	813.0	323.5
Nef, Week 28	494.0	444.0	455.0	283.0
Nef, Week 30	1220.0	512.0	357.0
Nef, Week 48	568.0	356.0	377.5
p17, Pre-vaccination	463.0	434.0	457.0	578.0
p17, Week 6	797.0	561.5	682.0	562.0
p17, Week 28	494.0	527.5	494.0	433.0
p17, Week 30	798.0	473.0	536.0
p17, Week 48	525.0	580.0	498.5
p24, Pre-vaccination	794.5	699.0	759.0	733.0
p24, Week 6	902.0	1033.0	977.0	943.0
p24, Week 28	784.0	670.5	726.0	883.0
p24, Week 30	988.0	708.0	944.5
p24, Week 48	856.0	831.0	891.0
RT, Pre-vaccination	494.5	442.0	455.0	474.0
RT, Week 6	1916.5	1426.5	1680.0	416.0
RT, Week 28	599.0	667.5	634.0	384.0
RT, Week 30	2138.0	540.0	477.0
RT, Week 48	797.5	573.0	470.0

36. Secondary Outcome

Title	Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine
Description	Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD8+ T-cells and F4co-Computed [frequency of CD8+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD8+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
F4co-Computed, Pre-vaccination	15895.5	19633.0	17609.0	25819.0
F4co-Computed, Week 6	16727.0	19340.0	17839.5	29786.5
F4co-Computed, Week 28	17526.0	17186.5	17344.0	25798.0
F4co-Computed, Week 30	15659.5	19210.0	29064.0
F4co-Computed, Week 48	16143.0	21063.0	25564.0
Nef, Pre-vaccination	3187.0	2453.0	3174.0	3796.0
Nef, Week 6	3141.0	3497.5	3141.0	5174.0
Nef, Week 28	2641.0	3655.0	3054.0	4332.0
Nef, Week 30	2790.0	3387.0	3970.5
Nef, Week 48	2444.5	2478.0	4014.5
p17, Pre-vaccination	858.0	1212.0	991.0	2246.0
p17, Week 6	829.0	1478.5	1085.0	1681.5
p17, Week 28	707.0	1419.0	1055.0	1613.0
p17, Week 30	510.0	1467.0	1524.0
p17, Week 48	818.0	1669.0	1494.0
p24, Pre-vaccination	5364.0	8630.0	6248.0	8435.0
p24, Week 6	4972.0	6826.0	5610.0	10328.0
p24, Week 28	6273.0	5465.5	6181.0	8207.0
p24, Week 30	5525.0	5064.0	8923.5
p24, Week 48	5900.0	6371.0	7410.0
RT, Pre-vaccination	3724.5	3073.0	3556.0	4395.0
RT, Week 6	3699.5	3418.0	3490.0	4715.0
RT, Week 28	6187.0	2860.5	3663.0	4292.0
RT, Week 30	3262.0	3747.5	4538.0
RT, Week 48	3299.5	3462.5	4565.0

37. Secondary Outcome

Title	Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens
Description	Breadth was assessed only for the CD4+ T-cells and was measured by evaluating response to at least 1, 2, 3 or all 4 antigens: proteins 17, 24, Nef, reverse transcriptase (RT).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
1 antigen, Pre-vaccination	30 48.4%	25 39.1%	55 85.9%	25 13.2%
2 antigens, Pre-vaccination	19 30.6%	16 25%	35 54.7%	18 9.5%
3 antigens, Pre-vaccination	11 17.7%	8 12.5%	19 29.7%	8 4.2%
4 antigens, Pre-vaccination	4 6.5%	3 4.7%	7 10.9%	3 1.6%
1 antigen, Week 6	28 45.2%	32 50%	60 93.8%	9 4.7%
2 antigens, Week 6	24 38.7%	24 37.5%	48 75%	2 1.1%
3 antigens, Week 6	12 19.4%	12 18.8%	24 37.5%	1 0.5%
4 antigens, Week 6	6 9.7%	6 9.4%	12 18.8%	0 0%
1 antigen, Week 28	19 30.6%	22 34.4%	41 64.1%	7 3.7%
2 antigens, Week 28	13 21%	11 17.2%	24 37.5%	4 2.1%
3 antigens, Week 28	4 6.5%	4 6.3%	8 12.5%	2 1.1%
4 antigens, Week 28	2 3.2%	3 4.7%	5 7.8%	1 0.5%
1 antigen, Week 30	30 48.4%	20 31.3%	14 21.9%
2 antigens, Week 30	24 38.7%	11 17.2%	5 7.8%
3 antigens, Week 30	15 24.2%	6 9.4%	3 4.7%
4 antigens, Week 30	8 12.9%	2 3.1%	0 0%
1 antigen, Week 48	23 37.1%	19 29.7%	13 20.3%
2 antigens, Week 48	17 27.4%	7 10.9%	3 4.7%
3 antigens, Week 48	5 8.1%	4 6.3%	2 3.1%
4 antigens, Week 48	4 6.5%	1 1.6%	0 0%

38. Secondary Outcome

Title	Cytokine Expression Profile of F4co-Computed CD4+ T Cells
Description	The cytokine co-expression profile was defined by the frequency of F4co-Computed CD4+ T-cells [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	41	42	79	37
CD40L, Pre-vaccination	772.0	299.5	453.0	493.0
CD40L, Week 6	355.0	472.0	427.0	153.0
CD40L, Week 28	560.5	453.0	506.5	442.0
CD40L, Week 30	452.0	760.5	716.5
CD40L, Week 48	383.0	481.5	653.0
IL-2, Pre-vaccination	118.0	45.5	70.0	93.5
IL-2, Week 6	127.0	72.0	91.5	58.0
IL-2, Week 28	63.0	59.0	63.0	34.0
IL-2, Week 30	103.0	92.5	46.5
IL-2, Week 48	74.0	58.0	86.0
TNF-α, Pre-vaccination	250.0	251.5	250.0	178.5
TNF-α, Week 6	346.0	251.0	277.5	166.5
TNF-α, Week 28	242.0	135.5	163.0	216.0
TNF-α, Week 30	389.0	101.5	223.0
TNF-α, Week 48	341.0	192.5	182.0
IFN- γ, Pre-vaccination	352.0	396.5	383.0	446.0
IFN- γ, Week 6	411.0	448.0	426.0	563.5
IFN- γ, Week 28	289.5	454.0	377.5	536.0
IFN- γ, Week 30	439.0	432.5	479.0
IFN- γ, Week 48	329.0	418.5	487.0
CD40L_IL-2, Pre-vaccination	149.0	149.5	149.0	77.5
CD40L_IL-2, Week 6	499.0	320.0	430.5	127.5
CD40L_IL-2, Week 28	199.0	196.0	198.0	56.0
CD40L_IL-2, Week 30	377.0	142.5	96.0
CD40L_IL-2, Week 48	172.0	218.0	102.0
CD40L_TNF-α, Pre-vaccination	201.0	116.0	154.0	88.5
CD40L_TNF-α, Week 6	416.0	275.0	374.5	110.0
CD40L_TNF-α, Week 28	152.5	101.0	129.5	130.0
CD40L_TNF-α, Week 30	413.0	144.5	195.5
CD40L_TNF-α, Week 48	164.0	160.5	201.0
CD40L_IFN- γ, Pre-vaccination	229.0	208.5	224.0	209.0
CD40L_IFN- γ, Week 6	375.0	233.0	280.5	307.0
CD40L_IFN- γ, Week 28	180.5	186.5	181.5	239.0
CD40L_IFN- γ, Week 30	325.0	195.5	254.5
CD40L_IFN- γ, Week 48	202.0	202.0	227.0
TNF-α_IL-2, Pre-vaccination	23.0	4.0	20.0	4.0
TNF-α_IL-2, Week 6	54.0	65.0	60.0	4.0
TNF-α_IL-2, Week 28	45.5	20.5	27.5	24.0
TNF-α_IL-2, Week 30	76.0	17.0	10.5
TNF-α_IL-2, Week 48	36.0	4.0	6.0
IFN- γ_IL-2, Pre-vaccination	4.0	4.0	4.0	4.0
IFN- γ_IL-2, Week 6	19.0	27.0	21.5	4.0
IFN- γ_IL-2, Week 28	4.0	4.0	4.0	4.0
IFN- γ_IL-2, Week 30	28.0	4.0	4.0
IFN- γ_IL-2, Week 48	4.0	4.0	4.0
TNF-α_IFN- γ, Pre-vaccination	94.0	92.0	93.0	149.5
TNF-α_IFN- γ, Week 6	132.0	123.0	127.0	165.0
TNF-α_IFN- γ, Week 28	111.5	141.5	129.5	90.0
TNF-α_IFN- γ, Week 30	110.0	127.0	153.5
TNF-α_IFN- γ, Week 48	72.0	98.5	143.0
CD40L_TNF-α_IL-2, Pre-vaccination	110.0	109.5	110.0	126.0
CD40L_TNF-α_IL-2, Week 6	889.0	529.0	730.5	134.0
CD40L_TNF-α_IL-2, Week 28	312.0	247.0	286.5	114.0
CD40L_TNF-α_IL-2, Week 30	953.0	244.5	182.5
CD40L_TNF-α_IL-2, Week 48	367.0	174.0	81.0
CD40L_IFN- γ_IL-2, Pre-vaccination	46.0	45.0	46.0	43.0
CD40L_IFN- γ_IL-2, Week 6	331.0	208.0	253.0	68.5
CD40L_IFN- γ_IL-2, Week 28	88.0	87.5	87.5	37.0
CD40L_IFN- γ_IL-2, Week 30	336.0	77.5	55.0
CD40L_IFN- γ_IL-2, Week 48	92.0	58.0	53.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	149.0	152.5	150.0	154.5
CD40L_TNF-α_IFN- γ, Week 6	341.0	264.0	289.0	172.5
CD40L_TNF-α_IFN- γ, Week 28	123.5	131.0	131.0	154.0
CD40L_TNF-α_IFN- γ, Week 30	291.0	149.5	142.0
CD40L_TNF-α_IFN- γ, Week 48	187.0	129.5	121.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	4.0	4.0	4.0	4.0
TNF-α_IFN- γ_IL-2, Week 6	40.0	21.0	32.5	4.0
TNF-α_IFN- γ_IL-2, Week 28	13.0	10.5	12.0	4.0
TNF-α_IFN- γ_IL-2, Week 30	36.0	4.0	4.0
TNF-α_IFN- γ_IL-2, Week 48	18.0	4.0	4.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	106.0	93.0	95.0	131.5
CD40L_TNF-α_IFN- γ_IL-2, Week 6	624.0	441.0	532.0	146.5
CD40L_TNF-α_IFN- γ_IL-2, Week 28	235.5	147.0	205.5	91.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	747.0	110.5	108.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	367.0	132.0	72.0

39. Secondary Outcome

Title	Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of Nef-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	41	42	79	37
CD40L, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L, Week 6	1.0	1.0	1.0	1.0
CD40L, Week 28	1.0	1.0	1.0	1.0
CD40L, Week 30	1.0	98.5	1.0
CD40L, Week 48	1.0	1.0	1.0
IL-2, Pre-vaccination	14.0	1.0	1.0	1.0
IL-2, Week 6	22.0	7.0	14.0	1.0
IL-2, Week 28	4.0	1.0	1.5	1.0
IL-2, Week 30	19.0	1.0	1.0
IL-2, Week 48	1.0	1.0	1.0
TNF-α, Pre-vaccination	18.0	1.0	1.0	1.0
TNF-α, Week 6	31.0	37.5	32.0	1.0
TNF-α, Week 28	5.0	1.0	1.0	1.0
TNF-α, Week 30	43.5	7.5	1.0
TNF-α, Week 48	82.5	1.0	1.0
IFN- γ, Pre-vaccination	84.0	62.5	83.0	87.0
IFN- γ, Week 6	101.0	105.5	103.0	81.0
IFN- γ, Week 28	24.0	114.5	67.0	101.0
IFN- γ, Week 30	83.0	118.5	99.5
IFN- γ, Week 48	61.5	69.0	79.0
CD40L_IL-2, Pre-vaccination	1.0	2.0	1.0	1.0
CD40L_IL-2, Week 6	111.0	65.5	78.0	16.0
CD40L_IL-2, Week 28	25.0	9.5	21.5	1.0
CD40L_IL-2, Week 30	112.5	1.0	1.0
CD40L_IL-2, Week 48	1.0	15.0	1.0
CD40L_TNF-α, Pre-vaccination	6.0	7.5	6.0	1.0
CD40L_TNF-α, Week 6	75.0	42.0	46.0	1.0
CD40L_TNF-α, Week 28	2.5	3.0	3.0	1.0
CD40L_TNF-α, Week 30	141.0	1.0	1.0
CD40L_TNF-α, Week 48	22.5	11.0	1.0
CD40L_IFN- γ, Pre-vaccination	1.0	7.5	1.0	20.0
CD40L_IFN- γ, Week 6	31.0	31.0	31.0	1.0
CD40L_IFN- γ, Week 28	1.0	12.5	1.0	1.0
CD40L_IFN- γ, Week 30	59.0	1.0	7.5
CD40L_IFN- γ, Week 48	10.0	1.0	1.0
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 28	15.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	7.5	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 30	1.0	1.0	1.0
IFN- γ_IL-2, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ, Pre-vaccination	1.0	21.5	15.0	20.0
TNF-α_IFN- γ, Week 6	26.0	8.0	19.0	14.0
TNF-α_IFN- γ, Week 28	18.0	3.0	15.0	24.0
TNF-α_IFN- γ, Week 30	14.5	45.5	17.5
TNF-α_IFN- γ, Week 48	1.0	13.0	16.0
CD40L_TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 6	207.0	110.5	137.0	1.0
CD40L_TNF-α_IL-2, Week 28	74.0	57.5	67.5	1.0
CD40L_TNF-α_IL-2, Week 30	327.0	38.5	1.5
CD40L_TNF-α_IL-2, Week 48	78.5	32.0	1.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 6	44.0	6.5	22.0	1.0
CD40L_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 30	74.5	1.0	1.0
CD40L_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 6	17.0	16.5	17.0	1.0
CD40L_TNF-α_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 30	43.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	77.0	53.0	66.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 28	26.0	7.5	20.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	142.5	14.5	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	43.0	1.0	1.0

40. Secondary Outcome

Title	Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of P17-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	41	42	79	37
CD40L, Pre-vaccination	180.0	1.0	68.0	1.0
CD40L, Week 6	1.0	1.0	1.0	1.0
CD40L, Week 28	100.0	60.5	80.0	1.0
CD40L, Week 30	1.0	133.0	198.0
CD40L, Week 48	1.0	72.0	150.0
IL-2, Pre-vaccination	1.0	1.0	1.0	9.0
IL-2, Week 6	1.5	20.0	6.0	1.0
IL-2, Week 28	1.0	27.5	1.5	1.0
IL-2, Week 30	12.0	1.0	1.0
IL-2, Week 48	1.0	9.0	1.0
TNF-α, Pre-vaccination	24.0	25.5	25.0	13.5
TNF-α, Week 6	26.5	41.5	36.0	31.5
TNF-α, Week 28	57.0	1.0	26.0	27.0
TNF-α, Week 30	51.0	1.0	1.5
TNF-α, Week 48	4.0	1.0	1.0
IFN- γ, Pre-vaccination	51.0	71.0	55.0	76.0
IFN- γ, Week 6	88.5	75.5	83.0	88.0
IFN- γ, Week 28	44.0	82.0	65.5	73.0
IFN- γ, Week 30	77.0	54.0	57.5
IFN- γ, Week 48	72.0	74.0	84.5
CD40L_IL-2, Pre-vaccination	31.0	6.0	23.0	1.0
CD40L_IL-2, Week 6	58.5	21.5	33.0	19.0
CD40L_IL-2, Week 28	34.5	20.0	28.0	1.0
CD40L_IL-2, Week 30	56.0	14.0	1.0
CD40L_IL-2, Week 48	1.0	42.0	34.5
CD40L_TNF-α, Pre-vaccination	24.0	16.0	21.0	6.5
CD40L_TNF-α, Week 6	58.5	34.5	45.0	30.5
CD40L_TNF-α, Week 28	39.5	6.0	23.0	26.0
CD40L_TNF-α, Week 30	26.0	22.0	21.5
CD40L_TNF-α, Week 48	11.0	20.0	32.5
CD40L_IFN- γ, Pre-vaccination	41.0	42.0	41.0	48.0
CD40L_IFN- γ, Week 6	76.0	42.0	56.0	70.0
CD40L_IFN- γ, Week 28	33.5	49.0	41.0	64.0
CD40L_IFN- γ, Week 30	79.0	35.0	56.0
CD40L_IFN- γ, Week 48	44.0	43.0	49.0
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 30	1.0	1.0	1.0
IFN- γ_IL-2, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ, Pre-vaccination	19.0	1.0	16.0	26.5
TNF-α_IFN- γ, Week 6	7.5	1.0	1.0	22.0
TNF-α_IFN- γ, Week 28	22.0	23.5	22.0	1.00
TNF-α_IFN- γ, Week 30	1.0	20.0	14.0
TNF-α_IFN- γ, Week 48	2.0	11.0	24.0
CD40L_TNF-α_IL-2, Pre-vaccination	4.0	16.5	10.0	26.0
CD40L_TNF-α_IL-2, Week 6	88.0	64.5	73.5	25.0
CD40L_TNF-α_IL-2, Week 28	51.0	25.0	31.5	6.0
CD40L_TNF-α_IL-2, Week 30	44.0	33.0	17.0
CD40L_TNF-α_IL-2, Week 48	33.0	15.0	1.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 6	26.5	25.0	25.0	1.0
CD40L_IFN- γ_IL-2, Week 28	1.0	18.5	12.5	1.0
CD40L_IFN- γ_IL-2, Week 30	20.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	37.0	35.0	35.0	37.0
CD40L_TNF-α_IFN- γ, Week 6	54.5	35.0	42.0	37.5
CD40L_TNF-α_IFN- γ, Week 28	32.5	28.5	30.5	26.0
CD40L_TNF-α_IFN- γ, Week 30	59.0	40.0	39.5
CD40L_TNF-α_IFN- γ, Week 48	26.0	16.0	22.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	22.0	8.5	20.0	12.5
CD40L_TNF-α_IFN- γ_IL-2, Week 6	50.0	71.5	64.0	30.5
CD40L_TNF-α_IFN- γ_IL-2, Week 28	22.5	8.5	21.0	25.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	46.0	13.0	27.5
CD40L_TNF-α_IFN- γ_IL-2, Week 48	42.0	25.0	14.0

41. Secondary Outcome

Title	Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of P24-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	41	42	79	37
CD40L, Pre-vaccination	115.0	65.0	114.0	70.0
CD40L, Week 6	86.0	140.5	110.0	1.0
CD40L, Week 28	125.0	194.0	165.0	15.0
CD40L, Week 30	22.5	110.0	130.5
CD40L, Week 48	1.0	160.0	125.0
IL-2, Pre-vaccination	21.0	3.0	5.0	1.0
IL-2, Week 6	1.0	6.0	1.0	1.0
IL-2, Week 28	2.5	1.0	1.0	1.0
IL-2, Week 30	22.0	1.0	1.0
IL-2, Week 48	1.0	1.0	19.0
TNF-α, Pre-vaccination	79.0	11.5	58.0	21.0
TNF-α, Week 6	24.5	32.5	32.0	1.0
TNF-α, Week 28	34.0	1.0	4.5	39.0
TNF-α, Week 30	65.0	1.0	20.5
TNF-α, Week 48	67.0	40.0	12.0
IFN- γ, Pre-vaccination	124.0	112.0	124.0	164.0
IFN- γ, Week 6	139.0	125.0	128.5	233.5
IFN- γ, Week 28	99.5	118.5	105.0	271.0
IFN- γ, Week 30	157.5	167.0	224.5
IFN- γ, Week 48	96.0	171.0	266.0
CD40L_IL-2, Pre-vaccination	43.0	22.0	35.0	22.0
CD40L_IL-2, Week 6	45.5	36.5	41.5	17.5
CD40L_IL-2, Week 28	31.0	31.5	31.5	13.0
CD40L_IL-2, Week 30	46.5	51.0	9.5
CD40L_IL-2, Week 48	30.0	34.0	2.0
CD40L_TNF-α, Pre-vaccination	68.0	30.0	58.0	38.0
CD40L_TNF-α, Week 6	55.0	72.0	64.5	26.0
CD40L_TNF-α, Week 28	49.0	13.0	29.5	46.0
CD40L_TNF-α, Week 30	86.5	48.0	61.5
CD40L_TNF-α, Week 48	63.0	6.0	48.0
CD40L_IFN- γ, Pre-vaccination	127.0	96.5	119.0	120.0
CD40L_IFN- γ, Week 6	122.5	81.5	98.0	129.5
CD40L_IFN- γ, Week 28	87.5	94.0	89.0	106.0
CD40L_IFN- γ, Week 30	113.5	106.0	137.5
CD40L_IFN- γ, Week 48	79.0	102.0	99.5
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	1.0	1.5	1.0	1.0
TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 30	1.0	1.0	1.0
IFN- γ_IL-2, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ, Pre-vaccination	22.0	42.0	35.0	53.0
TNF-α_IFN- γ, Week 6	34.0	34.0	34.0	56.5
TNF-α_IFN- γ, Week 28	28.0	41.5	33.5	29.0
TNF-α_IFN- γ, Week 30	26.5	43.0	52.0
TNF-α_IFN- γ, Week 48	24.0	40.0	46.0
CD40L_TNF-α_IL-2, Pre-vaccination	19.0	20.5	20.0	36.0
CD40L_TNF-α_IL-2, Week 6	98.0	80.0	87.0	29.5
CD40L_TNF-α_IL-2, Week 28	41.5	36.0	39.0	25.0
CD40L_TNF-α_IL-2, Week 30	79.5	44.0	32.5
CD40L_TNF-α_IL-2, Week 48	78.0	31.0	45.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	16.0
CD40L_IFN- γ_IL-2, Week 6	30.5	30.0	30.5	29.0
CD40L_IFN- γ_IL-2, Week 28	19.5	21.5	21.5	2.0
CD40L_IFN- γ_IL-2, Week 30	41.0	14.0	17.0
CD40L_IFN- γ_IL-2, Week 48	1.0	21.0	16.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	59.0	85.5	72.0	71.0
CD40L_TNF-α_IFN- γ, Week 6	68.0	84.5	74.5	62.5
CD40L_TNF-α_IFN- γ, Week 28	70.0	54.0	58.5	59.0
CD40L_TNF-α_IFN- γ, Week 30	83.5	57.0	83.5
CD40L_TNF-α_IFN- γ, Week 48	64.0	61.0	68.
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	41.0	38.0	40.0	36.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	62.5	58.0	59.0	52.5
CD40L_TNF-α_IFN- γ_IL-2, Week 28	52.0	41.0	49.5	27.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	85.5	46.0	24.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	57.0	53.0	24.0

42. Secondary Outcome

Title	Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	41	42	79	37
CD40L, Pre-vaccination	24.0	78.5	41.0	1.0
CD40L, Week 6	1.0	40.0	20.5	1.0
CD40L, Week 28	1.0	1.0	1.0	1.0
CD40L, Week 30	1.0	90.0	135.0
CD40L, Week 48	1.0	44.5	30.0
IL-2, Pre-vaccination	21.0	1.0	1.0	9.0
IL-2, Week 6	34.0	12.0	14.0	13.0
IL-2, Week 28	1.0	1.0	1.0	1.0
IL-2, Week 30	25.5	5.0	1.0
IL-2, Week 48	20.0	8.0	4.0
TNF-α, Pre-vaccination	61.0	18.0	40.0	46.0
TNF-α, Week 6	78.0	69.0	73.5	1.0
TNF-α, Week 28	40.0	1.0	1.0	41.0
TNF-α, Week 30	85.0	11.0	41.0
TNF-α, Week 48	59.5	1.0	30.0
IFN- γ, Pre-vaccination	21.0	25.5	23.0	45.0
IFN- γ, Week 6	85.0	27.0	65.0	28.0
IFN- γ, Week 28	18.5	27.0	21.5	44.0
IFN- γ, Week 30	57.5	40.0	47.0
IFN- γ, Week 48	42.0	46.0	55.0
CD40L_IL-2, Pre-vaccination	44.0	43.5	44.0	11.0
CD40L_IL-2, Week 6	183.0	179.0	181.0	27.0
CD40L_IL-2, Week 28	64.0	80.0	77.5	15.0
CD40L_IL-2, Week 30	118.5	57.0	30.0
CD40L_IL-2, Week 48	63.0	45.5	3.0
CD40L_TNF-α, Pre-vaccination	36.0	39.0	37.0	30.0
CD40L_TNF-α, Week 6	156.0	116.0	132.5	32.0
CD40L_TNF-α, Week 28	35.5	22.5	30.5	28.0
CD40L_TNF-α, Week 30	175.0	23.0	36.5
CD40L_TNF-α, Week 48	39.0	31.0	39.0
CD40L_IFN- γ, Pre-vaccination	26.0	17.5	22.0	23.0
CD40L_IFN- γ, Week 6	89.0	76.0	81.0	31.0
CD40L_IFN- γ, Week 28	15.5	1.0	5.5	23.0
CD40L_IFN- γ, Week 30	71.0	22.0	28.0
CD40L_IFN- γ, Week 48	31.0	7.5	30.0
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	22.0	24.0	22.5	1.0
TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	7.5	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 30	1.0	1.0	1.0
IFN- γ_IL-2, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ, Pre-vaccination	7.0	1.0	1.0	1.0
TNF-α_IFN- γ, Week 6	35.0	17.0	27.5	1.0
TNF-α_IFN- γ, Week 28	9.5	1.0	1.0	19.0
TNF-α_IFN- γ, Week 30	22.0	16.0	1.0
TNF-α_IFN- γ, Week 48	1.0	1.0	13.0
CD40L_TNF-α_IL-2, Pre-vaccination	23.0	25.5	23.0	23.0
CD40L_TNF-α_IL-2, Week 6	476.0	315.0	346.5	43.0
CD40L_TNF-α_IL-2, Week 28	142.0	95.0	121.5	49.0
CD40L_TNF-α_IL-2, Week 30	491.0	91.0	76.0
CD40L_TNF-α_IL-2, Week 48	185.0	66.0	20.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	6.5	1.0	9.0
CD40L_IFN- γ_IL-2, Week 6	141.0	96.0	123.5	14.0
CD40L_IFN- γ_IL-2, Week 28	26.5	17.0	21.0	1.0
CD40L_IFN- γ_IL-2, Week 30	131.0	20.0	1.0
CD40L_IFN- γ_IL-2, Week 48	21.0	11.5	1.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	18.0	1.5	14.0	27.0
CD40L_TNF-α_IFN- γ, Week 6	141.0	64.0	90.0	1.0
CD40L_TNF-α_IFN- γ, Week 28	14.5	17.5	15.5	19.0
CD40L_TNF-α_IFN- γ, Week 30	71.5	20.0	22.0
CD40L_TNF-α_IFN- γ, Week 48	25.5	21.5	21.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	18.0	1.0	7.0	1.0
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	7.5	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	29.0	14.0	20.0	23.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	371.0	262.0	337.0	56.0
CD40L_TNF-α_IFN- γ_IL-2, Week 28	100.5	70.0	85.5	18.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	459.5	48.0	34.5
CD40L_TNF-α_IFN- γ_IL-2, Week 48	96.0	58.0	33.0

43. Secondary Outcome

Title	Cytokine Expression Profile of F4co-Computed CD8+ T Cells
Description	The cytokine co-expression profile was defined by the frequency of F4co-Computed CD8+ T-cells [Frequency of CD8+ T cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
CD40L, Pre-vaccination	79.5	204.0	100.0	223.0
CD40L, Week 6	76.0	110.5	96.5	179.5
CD40L, Week 28	167.0	200.0	174.0	108.0
CD40L, Week 30	197.5	143.0	95.0
CD40L, Week 48	83.0	64.0	66.0
IL-2, Pre-vaccination	71.0	98.0	83.0	81.0
IL-2, Week 6	93.5	149.0	119.5	50.5
IL-2, Week 28	192.0	114.5	124.0	80.0
IL-2, Week 30	80.5	152.0	74.5
IL-2, Week 48	84.0	83.5	179.0
TNF-α, Pre-vaccination	183.5	213.0	192.0	314.0
TNF-α, Week 6	227.0	267.5	244.0	242.5
TNF-α, Week 28	195.0	158.5	178.0	227.0
TNF-α, Week 30	176.0	179.0	240.0
TNF-α, Week 48	246.0	200.5	273.0
IFN- γ, Pre-vaccination	13049.5	16362.0	15324.0	21932.0
IFN- γ, Week 6	15467.0	17126.0	16697.0	25219.0
IFN- γ, Week 28	16351.0	14143.0	14770.0	21406.0
IFN- γ, Week 30	13512.0	14730.0	25319.5
IFN- γ, Week 48	14423.0	18658.0	20890.0
CD40L_IL-2, Pre-vaccination	4.0	4.0	4.0	4.0
CD40L_IL-2, Week 6	4.0	4.0	4.0	4.0
CD40L_IL-2, Week 28	4.0	4.0	4.0	4.0
CD40L_IL-2, Week 30	4.0	4.0	4.0
CD40L_IL-2, Week 48	4.0	4.0	4.0
CD40L_TNF-α, Pre-vaccination	4.0	4.0	4.0	4.0
CD40L_TNF-α, Week 6	4.0	4.0	4.0	4.0
CD40L_TNF-α, Week 28	4.0	4.0	4.0	4.0
CD40L_TNF-α, Week 30	4.0	4.0	4.0
CD40L_TNF-α, Week 48	4.0	4.0	4.0
CD40L_IFN- γ, Pre-vaccination	19.5	21.0	21.0	35.0
CD40L_IFN- γ, Week 6	27.0	24.0	25.0	25.5
CD40L_IFN- γ, Week 28	23.0	19.0	21.0	22.0
CD40L_IFN- γ, Week 30	17.0	4.0	45.5
CD40L_IFN- γ, Week 48	31.0	21.5	28.0
TNF-α_IL-2, Pre-vaccination	4.0	4.0	4.0	4.0
TNF-α_IL-2, Week 6	4.0	4.0	4.0	4.0
TNF-α_IL-2, Week 28	4.0	4.0	4.0	4.0
TNF-α_IL-2, Week 30	4.0	4.0	4.0
TNF-α_IL-2, Week 48	4.0	4.0	4.0
IFN- γ_IL-2, Pre-vaccination	72.0	102.0	84.0	117.0
IFN- γ_IL-2, Week 6	70.0	111.0	84.5	119.0
IFN- γ_IL-2, Week 28	76.0	66.5	71.0	100.0
IFN- γ_IL-2, Week 30	51.0	103.0	74.5
IFN- γ_IL-2, Week 48	68.0	80.0	81.0
TNF-α_IFN- γ, Pre-vaccination	1049.5	1820.0	1469.0	2095.0
TNF-α_IFN- γ, Week 6	957.5	1864.5	1610.5	2199.0
TNF-α_IFN- γ, Week 28	1563.0	1782.5	1563.0	2012.0
TNF-α_IFN- γ, Week 30	985.0	1904.0	2260.0
TNF-α_IFN- γ, Week 48	993.0	1900.0	1787.0
CD40L_TNF-α_IL-2, Pre-vaccination	4.0	4.0	4.0	4.0
CD40L_TNF-α_IL-2, Week 6	4.0	4.0	4.0	4.0
CD40L_TNF-α_IL-2, Week 28	4.0	4.0	4.0	4.0
CD40L_TNF-α_IL-2, Week 30	4.0	4.0	4.0
CD40L_TNF-α_IL-2, Week 48	4.0	4.0	4.0
CD40L_IFN- γ_IL-2, Pre-vaccination	4.0	4.0	4.0	4.0
CD40L_IFN- γ_IL-2, Week 6	4.0	4.0	4.0	4.0
CD40L_IFN- γ_IL-2, Week 28	4.0	4.0	4.0	4.0
CD40L_IFN- γ_IL-2, Week 30	4.0	4.0	4.0
CD40L_IFN- γ_IL-2, Week 48	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	4.0	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ, Week 6	4.0	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ, Week 28	4.0	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ, Week 30	4.0	4.0	4.5
CD40L_TNF-α_IFN- γ, Week 48	4.0	4.0	17.0
TNF-α_IFN_IL-2, Pre-vaccination	17.0	36.0	30.0	40.0
TNF-α_IFN_IL-2, Week 6	9.5	18.5	16.0	58.0
TNF-α_IFN_IL-2, Week 28	15.0	19.0	17.0	21.0
TNF-α_IFN_IL-2, Week 30	4.0	22.0	30.5
TNF-α_IFN_IL-2, Week 48	33.0	19.5	26.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	4.0	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	4.0	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ_IL-2, Week 28	4.0	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	4.0	4.0	4.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	4.0	4.0	4.0

44. Secondary Outcome

Title	Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of Nef-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
CD40L, Pre-vaccination	1.0	1.0	1.0	51.0
CD40L, Week 6	1.0	1.0	1.0	1.0
CD40L, Week 28	16.0	12.5	16.0	1.0
CD40L, Week 30	5.0	1.0	1.0
CD40L, Week 48	1.0	1.0	1.0
IL-2, Pre-vaccination	1.0	4.0	1.0	1.0
IL-2, Week 6	1.0	6.0	1.0	1.0
IL-2, Week 28	1.0	14.0	1.0	19.0
IL-2, Week 30	1.0	35.0	1.0
IL-2, Week 48	1.0	1.0	4.5
TNF-α, Pre-vaccination	1.0	21.0	1.0	39.0
TNF-α, Week 6	32.0	31.5	32.0	42.5
TNF-α, Week 28	12.0	9.5	12.0	29.0
TNF-α, Week 30	1.0	1.0	50.0
TNF-α, Week 48	18.0	11.0	26.5
IFN- γ, Pre-vaccination	2947.0	2150.0	2646.0	3224.0
IFN- γ, Week 6	2942.0	2951.0	2942.0	4330.0
IFN- γ, Week 28	2396.0	2850.0	2748.0	3449.0
IFN- γ, Week 30	2586.0	2778.0	3469.0
IFN- γ, Week 48	2236.5	2228.0	3584.0
CD40L_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 30	1.0	1.0	1.0
CD40L_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 30	1.0	1.0	1.0
CD40L_TNF-α, Week 48	1.0	1.0	1.0
CD40L_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 30	1.0	1.0	1.0
CD40L_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	16.0
IFN- γ_IL-2, Week 6	1.0	11.5	1.0	22.5
IFN- γ_IL-2, Week 28	1.0	19.5	17.0	13.0
IFN- γ_IL-2, Week 30	1.0	18.0	12.5
IFN- γ_IL-2, Week 48	8.0	19.0	1.0
TNF-α_IFN- γ, Pre-vaccination	157.5	174.0	160.0	259.0
TNF-α_IFN- γ, Week 6	152.5	216.5	156.5	345.5
TNF-α_IFN- γ, Week 28	161.0	191.5	175.0	333.0
TNF-α_IFN- γ, Week 30	138.0	256.0	292.5
TNF-α_IFN- γ, Week 48	110.0	156.0	293.5
CD40L_TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 48	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	7.0
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0

45. Secondary Outcome

Title	Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of P17-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
CD40L, Pre-vaccination	1.0	9.0	7.0	20.0
CD40L, Week 6	1.0	23.0	2.0	17.0
CD40L, Week 28	15.0	42.5	40.0	4.0
CD40L, Week 30	1.0	3.0	1.0
CD40L, Week 48	1.0	1.0	1.0
IL-2, Pre-vaccination	1.0	29.0	7.0	1.0
IL-2, Week 6	17.0	16.0	17.0	4.5
IL-2, Week 28	19.0	37.5	37.0	1.0
IL-2, Week 30	1.0	1.0	22.0
IL-2, Week 48	2.0	1.0	21.0
TNF-α, Pre-vaccination	11.5	27.0	13.0	29.0
TNF-α, Week 6	25.0	39.5	29.0	19.0
TNF-α, Week 28	1.0	6.0	5.0	1.0
TNF-α, Week 30	2.5	1.0	11.0
TNF-α, Week 48	11.0	17.0	1.0
IFN- γ, Pre-vaccination	497.0	901.0	811.0	1617.0
IFN- γ, Week 6	642.0	1144.0	733.0	1450.5
IFN- γ, Week 28	694.0	1070.0	880.0	994.0
IFN- γ, Week 30	276.0	1199.5	1279.0
IFN- γ, Week 48	406.0	1049.0	1059.0
CD40L_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 30	1.0	1.0	1.0
CD40L_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 30	1.0	1.0	1.0
CD40L_TNF-α, Week 48	1.0	1.0	1.0
CD40L_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 30	1.0	1.0	1.0
CD40L_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 6	1.0	1.0	1.0	7.0
IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
IFN- γ_IL-2, Week 30	1.0	1.0	1.0
IFN- γ_IL-2, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ, Pre-vaccination	47.0	60.0	49.0	164.0
TNF-α_IFN- γ, Week 6	52.0	107.0	66.0	130.0
TNF-α_IFN- γ, Week 28	69.0	61.0	63.0	110.0
TNF-α_IFN- γ, Week 30	67.5	76.5	128.0
TNF-α_IFN- γ, Week 48	66.0	111.0	130.0
CD40L_TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 48	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0

46. Secondary Outcome

Title	Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of P24-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
CD40L, Pre-vaccination	1.0	26.0	3.0	54.0
CD40L, Week 6	1.0	10.0	1.0	26.5
CD40L, Week 28	1.0	25.5	7.0	28.0
CD40L, Week 30	38.0	18.0	1.5
CD40L, Week 48	1.0	1.0	1.0
IL-2, Pre-vaccination	1.0	2.0	1.0	1.0
IL-2, Week 6	1.0	5.5	2.0	1.0
IL-2, Week 28	1.0	21.5	12.0	1.0
IL-2, Week 30	8.0	35.5	1.0
IL-2, Week 48	1.0	4.0	11.0
TNF-α, Pre-vaccination	54.5	50.0	51.0	89.0
TNF-α, Week 6	37.0	82.5	71.0	40.0
TNF-α, Week 28	69.0	40.5	47.0	48.0
TNF-α, Week 30	29.0	19.0	74.5
TNF-α, Week 48	53.0	37.0	17.5
IFN- γ, Pre-vaccination	4897.0	6910.0	5933.0	6749.0
IFN- γ, Week 6	4570.0	5096.0	4657.0	9141.5
IFN- γ, Week 28	5862.0	4345.0	5268.0	6198.0
IFN- γ, Week 30	5056.0	4358.0	7770.0
IFN- γ, Week 48	5122.0	4974.0	6070.0
CD40L_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 30	1.0	1.0	1.0
CD40L_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 30	1.0	1.0	1.0
CD40L_TNF-α, Week 48	1.0	1.0	1.0
CD40L_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 30	1.0	1.0	11.5
CD40L_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	7.5	26.0	19.0	28.0
IFN- γ_IL-2, Week 6	1.0	19.0	1.0	22.0
IFN- γ_IL-2, Week 28	1.0	20.5	18.0	22.0
IFN- γ_IL-2, Week 30	11.0	18.5	25.0
IFN- γ_IL-2, Week 48	1.0	2.0	1.0
TNF-α_IFN- γ, Pre-vaccination	291.5	586.0	319.0	705.0
TNF-α_IFN- γ, Week 6	236.0	390.5	283.0	751.5
TNF-α_IFN- γ, Week 28	471.0	492.0	471.0	484.0
TNF-α_IFN- γ, Week 30	246.0	313.5	761.0
TNF-α_IFN- γ, Week 48	299.0	423.0	497.0
CD40L_TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 48	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	8.5
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0

47. Secondary Outcome

Title	Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells
Description	The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	38	40	75	35
CD40L, Pre-vaccination	1.0	60.0	1.0	12.0
CD40L, Week 6	1.0	15.0	1.0	35.0
CD40L, Week 28	1.0	1.0	1.0	1.0
CD40L, Week 30	19.0	1.0	1.0
CD40L, Week 48	1.0	1.0	1.0
IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
IL-2, Week 6	1.0	1.0	1.0	1.0
IL-2, Week 28	1.0	15.5	13.0	2.0
IL-2, Week 30	1.0	21.5	12.5
IL-2, Week 48	2.0	1.0	40.0
TNF-α, Pre-vaccination	71.5	67.0	68.0	84.0
TNF-α, Week 6	61.0	70.0	63.0	82.0
TNF-α, Week 28	42.0	50.0	48.0	80.0
TNF-α, Week 30	33.0	76.0	97.0
TNF-α, Week 48	63.5	63.0	109.0
IFN- γ, Pre-vaccination	3370.0	2161.0	3138.0	3950.0
IFN- γ, Week 6	3474.0	2885.0	3050.5	4012.0
IFN- γ, Week 28	5410.0	2355.5	3079.0	3595.0
IFN- γ, Week 30	2959.0	2824.5	4000.0
IFN- γ, Week 48	3081.0	3187.0	4294.0
CD40L_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IL-2, Week 30	1.0	1.0	1.0
CD40L_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α, Week 30	1.0	1.0	1.0
CD40L_TNF-α, Week 48	1.0	1.0	1.0
CD40L_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ, Week 30	1.0	1.0	1.0
CD40L_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IL-2, Week 30	1.0	1.0	1.0
TNF-α_IL-2, Week 48	1.0	1.0	1.0
IFN- γ_IL-2, Pre-vaccination	14.5	17.0	17.0	18.0
IFN- γ_IL-2, Week 6	1.0	28.0	23.5	16.0
IFN- γ_IL-2, Week 28	16.0	7.0	13.0	16.0
IFN- γ_IL-2, Week 30	1.0	11.5	19.0
IFN- γ_IL-2, Week 48	17.0	8.0	18.0
TNF-α_IFN- γ, Pre-vaccination	271.0	314.0	300.0	410.0
TNF-α_IFN- γ, Week 6	301.0	360.0	339.0	471.0
TNF-α_IFN- γ, Week 28	372.0	455.0	454.0	366.0
TNF-α_IFN- γ, Week 30	232.0	542.5	490.0
TNF-α_IFN- γ, Week 48	250.5	483.5	404.0
CD40L_TNF-α_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IL-2, Week 48	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ, Week 48	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	10.0
TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
TNF-α_IFN- γ_IL-2, Week 30	1.0	5.0	1.0
TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Pre-vaccination	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 6	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 28	1.0	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 30	1.0	1.0	1.0
CD40L_TNF-α_IFN- γ_IL-2, Week 48	1.0	1.0	1.0

48. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-P17 Antibodies
Description	Seropositivity rates for antibodies against P17 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 187 milli-ELISA units per milliliter (mEL.U/mL).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	44	45	89	40
Anti-P17, Pre-vaccination	35 56.5%	38 59.4%	73 114.1%	34 17.9%
Anti-P17, Week 6	39 62.9%	37 57.8%	76 118.8%	33 17.4%
Anti-P17, Week 28	37 59.7%	38 59.4%	75 117.2%	32 16.8%
Anti-P17, Week 30	41 66.1%	35 54.7%	31 48.4%
Anti-P17, Week 48	31 50%	33 51.6%	31 48.4%

49. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-P24 Antibodies
Description	Seropositivity rates for antibodies against P24 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 119 milli-ELISA units per milliliter (mEL.U/mL).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	44	45	89	40
Anti-P24, Pre-vaccination	42 67.7%	45 70.3%	87 135.9%	38 20%
Anti-P24, Week 6	43 69.4%	43 67.2%	86 134.4%	38 20%
Anti-P24, Week 28	43 69.4%	44 68.8%	87 135.9%	37 19.5%
Anti-P24, Week 30	43 69.4%	41 64.1%	36 56.3%
Anti-P24, Week 48	39 62.9%	42 65.6%	35 54.7%

50. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-Nef Antibodies
Description	Seropositivity rates for antibodies against Nef antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 494 milli-ELISA units per milliliter (mEL.U/mL).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	44	45	89	40
Anti-Nef, Pre-vaccination	22 35.5%	28 43.8%	50 78.1%	21 11.1%
Anti-Nef, Week 6	38 61.3%	35 54.7%	73 114.1%	17 8.9%
Anti-Nef, Week 28	24 38.7%	31 48.4%	55 85.9%	20 10.5%
Anti-Nef, Week 30	42 67.7%	28 43.8%	20 31.3%
Anti-Nef, Week 48	33 53.2%	27 42.2%	18 28.1%

51. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-RT Antibodies
Description	Seropositivity rates for antibodies against RT antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 125 milli-ELISA units per milliliter (mEL.U/mL).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	44	45	89	40
Anti-RT, Pre-vaccination	40 64.5%	42 65.6%	82 128.1%	39 20.5%
Anti-RT, Week 6	43 69.4%	42 65.6%	85 132.8%	40 21.1%
Anti-RT, Week 28	44 71%	45 70.3%	89 139.1%	38 20%
Anti-RT, Week 30	42 67.7%	41 64.1%	38 59.4%
Anti-RT, Week 48	38 61.3%	41 64.1%	37 57.8%

52. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-F4co Antibodies
Description	Seropositivity rates for antibodies against F4co antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 42 milli-ELISA units per milliliter (mEL.U/mL).
Time Frame	During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.

Arm/Group Title	3D_HIV Group	2D_HIV Group	HIV Group	Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4, administered intramuscularly in the deltoid of the non-dominant arm.	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Measure Participants	44	45	89	40
Anti-F4co, Pre-vaccination	44 71%	45 70.3%	89 139.1%	40 21.1%
Anti-F4co, Week 6	44 71%	43 67.2%	87 135.9%	40 21.1%
Anti-F4co, Week 28	44 71%	45 70.3%	89 139.1%	39 20.5%
Anti-F4co, Week 30	43 69.4%	42 65.6%	38 59.4%
Anti-F4co, Week 48	39 62.9%	43 67.2%	37 57.8%

Adverse Events

Time Frame	Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 28-day (Days 0-27) post-vaccination period; SAEs: during the entire study period (Week 0 to Week 48).
Arm/Group Title	3D_HIV Group		2D_HIV Group		Control Group
Arm/Group Description	HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.		HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.		HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
All Cause Mortality
	3D_HIV Group		2D_HIV Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/64 (0%)		0/64 (0%)
Serious Adverse Events
	3D_HIV Group		2D_HIV Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/62 (1.6%)		3/64 (4.7%)		2/64 (3.1%)
Blood and lymphatic system disorders
Anaemia	0/62 (0%)	0	0/64 (0%)	0	1/64 (1.6%)	1
Infections and infestations
Appendicitis	1/62 (1.6%)	1	0/64 (0%)	0	0/64 (0%)	0
Gastroenteritis shigella	1/62 (1.6%)	1	0/64 (0%)	0	0/64 (0%)	0
Hepatitis c	0/62 (0%)	0	1/64 (1.6%)	1	0/64 (0%)	0
Lymph node tuberculosis	0/62 (0%)	0	1/64 (1.6%)	1	0/64 (0%)	0
Injury, poisoning and procedural complications
Skull fracture	0/62 (0%)	0	0/64 (0%)	0	1/64 (1.6%)	1
Nervous system disorders
Haemorrhage intracranial	0/62 (0%)	0	0/64 (0%)	0	1/64 (1.6%)	1
Hydrocephalus	0/62 (0%)	0	0/64 (0%)	0	1/64 (1.6%)	1
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia	0/62 (0%)	0	0/64 (0%)	0	1/64 (1.6%)	1
Psychiatric disorders
Anxiety	0/62 (0%)	0	1/64 (1.6%)	1	0/64 (0%)	0
Renal and urinary disorders
Hydronephrosis	0/62 (0%)	0	0/64 (0%)	0	1/64 (1.6%)	1
Skin and subcutaneous tissue disorders
Angioedema	0/62 (0%)	0	1/64 (1.6%)	1	0/64 (0%)	0
Other (Not Including Serious) Adverse Events
	3D_HIV Group		2D_HIV Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/62 (96.8%)		60/64 (93.8%)		42/64 (65.6%)
Gastrointestinal disorders
Abdominal pain	13/62 (21%)	18	10/64 (15.6%)	13	4/64 (6.3%)	6
Diarrhoea	18/62 (29%)	23	20/64 (31.3%)	29	15/64 (23.4%)	19
Nausea	17/62 (27.4%)	24	15/64 (23.4%)	18	8/64 (12.5%)	8
General disorders
Fatigue	43/62 (69.4%)	83	39/64 (60.9%)	66	20/64 (31.3%)	34
Pain	58/62 (93.5%)	146	57/64 (89.1%)	115	14/64 (21.9%)	20
Pyrexia	14/62 (22.6%)	18	9/64 (14.1%)	11	7/64 (10.9%)	8
Swelling	4/62 (6.5%)	6	8/64 (12.5%)	10	0/64 (0%)	0
Infections and infestations
Nasopharyngitis	4/62 (6.5%)	4	4/64 (6.3%)	4	4/64 (6.3%)	4
Metabolism and nutrition disorders
Decreased appetite	11/62 (17.7%)	13	10/64 (15.6%)	11	7/64 (10.9%)	7
Musculoskeletal and connective tissue disorders
Myalgia	33/62 (53.2%)	61	33/64 (51.6%)	55	13/64 (20.3%)	21
Nervous system disorders
Headache	32/62 (51.6%)	57	33/64 (51.6%)	57	22/64 (34.4%)	32
Skin and subcutaneous tissue disorders
Erythema	18/62 (29%)	23	14/64 (21.9%)	19	0/64 (0%)	0
Hyperhidrosis	11/62 (17.7%)	21	20/64 (31.3%)	27	10/64 (15.6%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.