Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00434512

Collaborator

(none)

180

Enrollment

Location

Arms

15.7

Actual Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag, pol and nef). The principal objectives of this study are to evaluate the reactogenicity and safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three different doses and to evaluate the CD4+ T-cell response in terms of proportion of responders to the antigens two weeks after the second vaccination.

Condition or Disease	Intervention/Treatment	Phase
AIDS HIV Infections	Biological: HIV vaccine 732461	Phase 2

Detailed Description

This is a single center, observer-blind, randomized, dose-escalating, staggered study with 6 groups: 3 groups of 50 subjects receiving the adjuvanted candidate vaccine, at 3 different doses and 3 groups of 10 subjects receiving the non-adjuvanted candidate vaccine in water for injection, at 3 different doses. The vaccination schedule will be 0-1 month. Blood samples will be collected at 8 visits. The duration of the study will be approximately 14 months for each subject. Rationale for Protocol Posting Amendment: The third vaccination will be cancelled and the visit at Month 7 will be postponed to Month 9. The Protocol Posting has also been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Dose-ranging Study to Compare the Safety and Immunogenicity of a Candidate Human Deficiency Virus (HIV) Vaccine 732461, Adjuvanted or Not, Administered According to a 0, 1 Month Schedule to Healthy Adult HIV Seronegative Volunteers.

Actual Study Start Date :

Feb 20, 2007

Actual Primary Completion Date :

Jun 13, 2008

Actual Study Completion Date :

Jun 13, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SB732461 adjuvanted_LD Group Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Biological: HIV vaccine 732461
Experimental: SB732461 adjuvanted_MD Group Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Biological: HIV vaccine 732461
Experimental: SB732461 adjuvanted_HD Group Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Biological: HIV vaccine 732461
Experimental: SB732461 non-adjuvanted_LD Group Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Biological: HIV vaccine 732461
Experimental: SB732461 non-adjuvanted_MD Group Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Biological: HIV vaccine 732461
Experimental: SB732461 non-adjuvanted_HD Group Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Biological: HIV vaccine 732461

Outcome Measures

Primary Outcome Measures

Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)]
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)]
Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [During the 30-day (Days 0-29) follow-up period after vaccination (across doses)]
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 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs) and Related SAEs [During the whole study period (From Month 0 up to Month 12)]
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.
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0 [At Month 0]
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1 [At Month 1]
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44 [At Day 44]
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2 [At Month 2]
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6 [At Month 6]
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9 [At Month 9]
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12 [At Month 12]
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens [At Day 44]
Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.

Secondary Outcome Measures

Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker [At Month 0, Day 44, Month 2, Month 6 and Month 12]
Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers [At Month 0, Day 44, Month 2, Month 6 and Month 12]
Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens [At Month 0, Day 44, Month 2, Month 6 and Month 12]
Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

A male or female between and including 18-40 years at the time of first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Good general health without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Negative for antibodies against HIV-1, HIV-2 and negative for HIV p24 antigen within 56 days (8 weeks) prior to enrolment. Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
Negative for anti-HBc Ab, HBsAg and anti-HCV Ab.

Exclusion Criteria:

Women who are pregnant or breast-feeding.
Subjects with a history of, or current, alcohol or substance abuse.
The subject is at high risk of acquiring HIV according to the behavioural risk assessment questionnaire.
Morbid obesity
Previous inclusion in a HIV vaccines trial.
Receipt of live attenuated vaccines within 30 days of enrolment.
Receipt of medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days of study vaccine administration.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Prior receipt of HIV-1 vaccines or placebo in a previous HIV vaccine trial.
Receipt of blood products 120 days prior to HIV screening.
Receipt of immunoglobulin 120 days prior to HIV screening.
History of serious adverse reactions including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain to vaccines.
History of serious allergic reaction to any substance requiring hospitalization or emergency medical care.
History of immunodeficiency or autoimmune disease.
History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination.
History of type I or type II diabetes mellitus including cases controlled with diet alone. A subject with past gestational diabetes is eligible.
Thyroid disease including history of thyroidectomy and diagnoses requiring medication. A subject not requiring thyroid medicine within the past 12 months is eligible.
Acute disease at the time of enrolment.
Asthma requiring daily steroid or long acting β agonist prevention.
Unstable asthma.
Food- or wine-induced asthma.
Known sensitivity to sulfites or aspirin.
Bleeding disorder that was diagnosed by a physician. A subject who states that he or she has easy bruising or bleeding, but does not carry a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
History of any serious neurologic disorder or seizure
History of major congenital defect
History of chronic fatigue syndrome or fibromyalgia
Splenectomy
Hypertension. A subject with hypertension is eligible if he or she is controlled on medication and the documented blood pressure is less than 150/100.
Any medical, psychiatric or social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contradiction to adherence to the study protocol or ability to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Gent		Belgium	9000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00434512

Other Study ID Numbers:

108706
2006-003796-12

First Posted:

Feb 13, 2007

Last Update Posted:

Oct 1, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by GlaxoSmithKline

Additional relevant MeSH terms:

HIV Infections

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	A total of 229 subjects were enrolled and screened in this study, and 49 of these were excluded before vaccination.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Period Title: Overall Study
STARTED	10	10	10	50	50	50
COMPLETED	10	9	10	49	49	49
NOT COMPLETED	0	1	0	1	1	1

Baseline Characteristics

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group	Total
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Total of all reporting groups
Overall Participants	10	10	10	50	50	50	180
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	21.4 (3.75)	21.8 (3.19)	22.5 (4.99)	22.0 (5.04)	22.2 (3.66)	22.9 (5.43)	22.3 (4.62)
Sex: Female, Male (Count of Participants)
Female	7 70%	7 70%	7 70%	33 66%	28 56%	32 64%	114 63.3%
Male	3 30%	3 30%	3 30%	17 34%	22 44%	18 36%	66 36.7%
Race/Ethnicity, Customized (Count of Participants)
White - Arabic/North African heritage	1 10%	0 0%	0 0%	0 0%	1 2%	0 0%	2 1.1%
White - Caucasian/European heritage	7 70%	10 100%	10 100%	50 100%	47 94%	50 100%	174 96.7%
Other - Unspecified	2 20%	0 0%	0 0%	0 0%	2 4%	0 0%	4 2.2%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame	During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	10	10	50	50	50
Any Pain, Dose 1	2 20%	0 0%	2 20%	49 98%	49 98%	49 98%
Grade 3 Pain, Dose 1	0 0%	0 0%	0 0%	4 8%	1 2%	4 8%
Any Redness, Dose 1	0 0%	0 0%	0 0%	5 10%	18 36%	9 18%
Grade 3 Redness, Dose 1	0 0%	0 0%	0 0%	3 6%	9 18%	2 4%
Any Swelling, Dose 1	0 0%	0 0%	0 0%	9 18%	12 24%	5 10%
Grade 3 Swelling, Dose 1	0 0%	0 0%	0 0%	5 10%	2 4%	1 2%
Any Pain, Dose 2	3 30%	2 20%	4 40%	47 94%	49 98%	48 96%
Grade 3 Pain, Dose 2	0 0%	0 0%	0 0%	6 12%	4 8%	6 12%
Any Redness, Dose 2	0 0%	0 0%	0 0%	14 28%	17 34%	25 50%
Grade 3 Redness, Dose 2	0 0%	0 0%	0 0%	5 10%	11 22%	10 20%
Any Swelling, Dose 2	0 0%	0 0%	0 0%	11 22%	13 26%	17 34%
Grade 3 Swelling, Dose 2	0 0%	0 0%	0 0%	4 8%	2 4%	3 6%
Any Pain, Overall	3 30%	2 20%	5 50%	49 98%	50 100%	50 100%
Grade 3 Pain, Overall	0 0%	0 0%	0 0%	7 14%	5 10%	10 20%
Any Redness, Overall	0 0%	0 0%	0 0%	14 28%	23 46%	25 50%
Grade 3 Redness, Overall	0 0%	0 0%	0 0%	7 14%	13 26%	12 24%
Any Swelling, Overall	0 0%	0 0%	0 0%	13 26%	18 36%	19 38%
Grade 3 Swelling, Overall	0 0%	0 0%	0 0%	6 12%	3 6%	4 8%

2. Primary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	10	10	50	50	50
Any Fatigue, Dose 1	3 30%	5 50%	5 50%	27 54%	28 56%	33 66%
Grade 3 Fatigue, Dose 1	0 0%	0 0%	0 0%	2 4%	0 0%	1 2%
Related Fatigue, Dose 1	2 20%	4 40%	3 30%	26 52%	24 48%	32 64%
Any Fever, Dose 1	0 0%	0 0%	0 0%	3 6%	3 6%	3 6%
Grade 3 Fever, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Fever, Dose 1	0 0%	0 0%	0 0%	3 6%	3 6%	3 6%
Any Gastrointestinal, Dose 1	1 10%	1 10%	1 10%	9 18%	9 18%	8 16%
Grade 3 Gastrointestinal, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Gastrointestinal, Dose 1	1 10%	0 0%	1 10%	8 16%	6 12%	5 10%
Any Headache, Dose 1	2 20%	4 40%	3 30%	24 48%	21 42%	24 48%
Grade 3 Headache, Dose 1	0 0%	0 0%	0 0%	2 4%	0 0%	2 4%
Related Headache, Dose 1	0 0%	3 30%	2 20%	20 40%	19 38%	21 42%
Any Myalgia, Dose 1	2 20%	1 10%	1 10%	13 26%	20 40%	23 46%
Grade 3 Myalgia, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	4 8%
Related Myalgia, Dose 1	2 20%	1 10%	1 10%	13 26%	19 38%	21 42%
Any Sweating, Dose 1	0 0%	0 0%	2 20%	7 14%	8 16%	11 22%
Grade 3 Sweating, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Sweating, Dose 1	0 0%	0 0%	2 20%	6 12%	6 12%	10 20%
Any Fatigue, Dose 2	3 30%	2 20%	4 40%	39 78%	43 86%	44 88%
Grade 3 Fatigue, Dose 2	0 0%	0 0%	0 0%	9 18%	7 14%	11 22%
Related Fatigue, Dose 2	3 30%	1 10%	3 30%	39 78%	43 86%	44 88%
Any Fever, Dose 2	0 0%	0 0%	0 0%	29 58%	29 58%	25 50%
Grade 3 Fever, Dose 2	0 0%	0 0%	0 0%	3 6%	2 4%	1 2%
Related Fever, Dose 2	0 0%	0 0%	0 0%	29 58%	29 58%	25 50%
Any Gastrointestinal, Dose 2	1 10%	1 10%	2 20%	20 40%	15 30%	13 26%
Grade 3 Gastrointestinal, Dose 2	0 0%	0 0%	0 0%	2 4%	2 4%	2 4%
Related Gastrointestinal, Dose 2	1 10%	1 10%	2 20%	19 38%	12 24%	11 22%
Any Headache, Dose 2	2 20%	1 10%	2 20%	38 76%	37 74%	37 74%
Grade 3 Headache, Dose 2	0 0%	0 0%	0 0%	8 16%	5 10%	6 12%
Related Headache, Dose 2	1 10%	1 10%	2 20%	37 74%	37 74%	37 74%
Any Myalgia, Dose 2	0 0%	1 10%	1 10%	31 62%	31 62%	28 56%
Grade 3 Myalgia, Dose 2	0 0%	0 0%	0 0%	5 10%	6 12%	7 14%
Related Myalgia, Dose 2	0 0%	1 10%	1 10%	31 62%	31 62%	28 56%
Any Sweating, Dose 2	1 10%	1 10%	1 10%	28 56%	24 48%	23 46%
Grade 3 Sweating, Dose 2	0 0%	0 0%	0 0%	3 6%	2 4%	4 8%
Related Sweating, Dose 2	1 10%	1 10%	1 10%	26 52%	24 48%	23 46%
Any Fatigue, Overall	5 50%	5 50%	6 60%	40 80%	47 94%	46 92%
Grade 3 Fatigue, Overall	0 0%	0 0%	0 0%	11 22%	7 14%	12 24%
Related Fatigue, Overall	5 50%	4 40%	5 50%	40 80%	46 92%	46 92%
Any Fever, Overall	0 0%	0 0%	0 0%	30 60%	29 58%	26 52%
Grade 3 Fever, Overall	0 0%	0 0%	0 0%	3 6%	2 4%	1 2%
Related Fever, Overall	0 0%	0 0%	0 0%	30 60%	29 58%	26 52%
Any Gastrointestinal, Overall	2 20%	2 20%	2 20%	23 46%	21 42%	17 34%
Grade 3 Gastrointestinal, Overall	0 0%	0 0%	0 0%	2 4%	2 4%	2 4%
Related Gastrointestinal, Overall	2 20%	1 10%	2 20%	22 44%	16 32%	13 26%
Any Headache, Overall	4 40%	4 40%	5 50%	42 84%	42 84%	41 82%
Grade 3 Headache, Overall	0 0%	0 0%	0 0%	10 20%	5 10%	8 16%
Related Headache, Overall	1 10%	3 30%	4 40%	40 80%	42 84%	41 82%
Any Myalgia, Overall	2 20%	1 10%	2 20%	31 62%	35 70%	36 72%
Grade 3 Myalgia, Overall	0 0%	0 0%	0 0%	5 10%	6 12%	8 16%
Related Myalgia, Overall	2 20%	1 10%	2 20%	31 62%	35 70%	35 70%
Any Sweating, Overall	1 10%	1 10%	3 30%	28 56%	27 54%	26 52%
Grade 3 Sweating, Overall	0 0%	0 0%	0 0%	3 6%	2 4%	4 8%
Related Sweating, Overall	1 10%	1 10%	3 30%	27 54%	27 54%	26 52%

3. Primary Outcome

Title	Number of Subjects With Any, Grade 3 and Related 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 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame	During the 30-day (Days 0-29) follow-up period after vaccination (across doses)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	10	10	50	50	50
Any AE(s)	5 50%	6 60%	7 70%	42 84%	30 60%	33 66%
Grade 3 AE(s)	0 0%	1 10%	0 0%	9 18%	5 10%	6 12%
Related AE(s)	0 0%	0 0%	1 10%	22 44%	15 30%	15 30%

4. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs) and Related 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 whole study period (From Month 0 up to Month 12)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	10	10	50	50	50
SAEs	0 0%	0 0%	0 0%	2 4%	2 4%	2 4%
SAEs	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

5. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Description	The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Time Frame	At Month 0

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	50	10	50	10	50
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	2 20%	1 10%	1 2%	1 2%	2 4%
Within	10 100%	48 480%	9 90%	49 98%	9 18%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	4 40%	1 10%	0 0%	0 0%	1 2%
Within	10 100%	46 460%	9 90%	49 98%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	3 30%	1 10%	1 2%	1 2%	2 4%
Within	10 100%	47 470%	9 90%	49 98%	9 18%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	1 10%	1 10%	0 0%	4 8%	0 0%	6 12%
Within	9 90%	47 470%	10 100%	45 90%	10 20%	44 88%
Above	0 0%	2 20%	0 0%	1 2%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	2 20%	0 0%	2 4%	0 0%	3 6%
Within	9 90%	43 430%	10 100%	46 92%	10 20%	47 94%
Above	1 10%	5 50%	0 0%	2 4%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	1 10%	6 60%	0 0%	2 4%	0 0%	0 0%
Within	9 90%	44 440%	10 100%	46 92%	10 20%	48 96%
Above	0 0%	0 0%	0 0%	2 4%	0 0%	2 4%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	3 30%	0 0%	0 0%	0 0%	0 0%
Within	9 90%	40 400%	7 70%	40 80%	7 14%	39 78%
Above	1 10%	7 70%	3 30%	10 20%	3 6%	11 22%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	7 70%	47 470%	9 90%	49 98%	10 20%	49 98%
Above	3 30%	3 30%	1 10%	1 2%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	50 100%	10 20%	50 100%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	1 10%	0 0%	0 0%	2 4%	1 2%	1 2%
Within	9 90%	50 500%	10 100%	48 96%	9 18%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	10 100%	50 100%	10 20%	50 100%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	2 20%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	10 100%	49 98%	9 18%	50 100%
Above	0 0%	0 0%	0 0%	1 2%	1 2%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	10 100%	50 100%	10 20%	50 100%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Within	10 100%	49 490%	9 90%	48 96%	10 20%	49 98%
Above	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	48 96%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	2 4%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	2 20%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	10 100%	50 100%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%

6. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Description	The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Time Frame	At Month 1

Outcome Measure Data

Analysis Population Description
The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	50	10	50	10	50
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	50 100%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	2 20%	0 0%	1 2%	0 0%	0 0%
Within	10 100%	48 480%	10 100%	49 98%	10 20%	50 100%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	4 40%	0 0%	1 2%	0 0%	0 0%
Within	10 100%	46 460%	10 100%	49 98%	10 20%	50 100%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	1 10%	0 0%	7 14%	0 0%	4 8%
Within	10 100%	48 480%	10 100%	42 84%	10 20%	45 90%
Above	0 0%	1 10%	0 0%	1 2%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	2 20%	1 10%	5 10%	0 0%	4 8%
Within	10 100%	46 460%	9 90%	44 88%	10 20%	43 86%
Above	0 0%	2 20%	0 0%	1 2%	0 0%	3 6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	2 20%	0 0%	0 0%	0 0%	3 6%
Within	10 100%	47 470%	9 90%	47 94%	10 20%	43 86%
Above	0 0%	1 10%	1 10%	3 6%	0 0%	4 8%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Within	7 70%	38 380%	6 60%	39 78%	5 10%	31 62%
Above	3 30%	11 110%	4 40%	11 22%	5 10%	19 38%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	9 90%	44 440%	9 90%	44 88%	10 20%	47 94%
Above	1 10%	6 60%	1 10%	6 12%	0 0%	3 6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	50 100%	10 20%	50 100%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	1 2%	2 4%
Within	10 100%	50 500%	10 100%	50 100%	9 18%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	48 96%	9 18%	49 98%
Above	0 0%	0 0%	0 0%	2 4%	1 2%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	47 470%	10 100%	47 94%	10 20%	45 90%
Above	0 0%	2 20%	0 0%	3 6%	0 0%	5 10%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	9 90%	50 100%	10 20%	49 98%
Above	0 0%	1 10%	1 10%	0 0%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Within	10 100%	48 480%	10 100%	48 96%	10 20%	50 100%
Above	0 0%	2 20%	0 0%	1 2%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	10 100%	49 98%	10 20%	47 94%
Above	0 0%	1 10%	0 0%	1 2%	0 0%	3 6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	1 10%	0 0%	1 2%	0 0%	0 0%
Within	10 100%	49 490%	10 100%	48 96%	10 20%	47 94%
Above	0 0%	0 0%	0 0%	1 2%	0 0%	3 6%

7. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Description	The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Time Frame	At Day 44

Outcome Measure Data

Analysis Population Description
The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	50	10	50	10	50
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Within	10 100%	50 500%	10 100%	49 98%	10 20%	47 94%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	1 10%	1 10%	0 0%	2 4%	2 4%	2 4%
Within	9 90%	49 490%	10 100%	48 96%	8 16%	46 92%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	1 10%	2 20%	0 0%	2 4%	2 4%	4 8%
Within	9 90%	48 480%	10 100%	48 96%	8 16%	44 88%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	1 10%	0 0%	1 10%	4 8%	0 0%	0 0%
Within	9 90%	48 480%	9 90%	46 92%	10 20%	47 94%
Above	0 0%	2 20%	0 0%	0 0%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	2 20%	1 10%	3 6%	1 2%	1 2%
Within	10 100%	47 470%	9 90%	47 94%	8 16%	46 92%
Above	0 0%	1 10%	0 0%	0 0%	1 2%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	2 20%	0 0%	0 0%	1 2%	2 4%
Within	10 100%	46 460%	9 90%	47 94%	8 16%	45 90%
Above	0 0%	2 20%	1 10%	3 6%	1 2%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	1 10%	0 0%	0 0%	0 0%	0 0%	2 4%
Within	6 60%	44 440%	7 70%	42 84%	6 12%	34 68%
Above	3 30%	6 60%	3 30%	8 16%	4 8%	12 24%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	8 80%	46 460%	9 90%	46 92%	10 20%	47 94%
Above	2 20%	4 40%	1 10%	4 8%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	50 100%	10 20%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Within	10 100%	50 500%	10 100%	50 100%	10 20%	47 94%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	9 90%	50 500%	10 100%	50 100%	10 20%	48 96%
Above	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Within	10 100%	48 480%	10 100%	49 98%	10 20%	46 92%
Above	0 0%	2 20%	0 0%	1 2%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	10 100%	49 98%	10 20%	47 94%
Above	0 0%	2 20%	0 0%	1 2%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	1 10%	0 0%	0 0%	0 0%	1 2%	2 4%
Within	9 90%	47 470%	10 100%	50 100%	9 18%	43 86%
Above	0 0%	3 30%	0 0%	0 0%	0 0%	3 6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	49 98%	10 20%	48 96%
Above	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Below	0 0%	1 10%	0 0%	0 0%	0 0%	1 2%
Within	10 100%	48 480%	10 100%	49 98%	10 20%	47 94%
Above	0 0%	1 10%	0 0%	1 2%	0 0%	0 0%

8. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Description	The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Time Frame	At Month 2

Outcome Measure Data

Analysis Population Description
The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	50	10	50	10	50
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	1 10%	1 2%	0 0%	0 0%
Within	10 100%	50 500%	9 90%	48 96%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	1 10%	3 30%	1 10%	2 4%	1 2%	1 2%
Within	9 90%	47 470%	9 90%	47 94%	9 18%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	1 10%	3 30%	1 10%	1 2%	1 2%	0 0%
Within	9 90%	47 470%	9 90%	48 96%	9 18%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	2 20%	1 10%	0 0%	5 10%	1 2%	5 10%
Within	8 80%	48 480%	10 100%	43 86%	9 18%	43 86%
Above	0 0%	1 10%	0 0%	1 2%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	1 10%	3 30%	1 10%	4 8%	0 0%	5 10%
Within	9 90%	45 450%	9 90%	45 90%	10 20%	42 84%
Above	0 0%	2 20%	0 0%	0 0%	0 0%	2 4%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	2 20%	0 0%	1 2%	0 0%	3 6%
Within	10 100%	48 480%	9 90%	43 86%	10 20%	42 84%
Above	0 0%	0 0%	1 10%	5 10%	0 0%	4 8%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	6 60%	43 430%	5 50%	37 74%	9 18%	33 66%
Above	4 40%	7 70%	5 50%	12 24%	1 2%	16 32%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	7 70%	47 470%	9 90%	41 82%	10 20%	46 92%
Above	3 30%	3 30%	1 10%	8 16%	0 0%	3 6%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	49 98%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	2 20%	0 0%	0 0%	1 2%	1 2%
Within	10 100%	48 480%	10 100%	48 96%	9 18%	48 96%
Above	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%
Within	10 100%	50 500%	9 90%	48 96%	9 18%	49 98%
Above	0 0%	0 0%	1 10%	1 2%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	1 2%	1 2%	0 0%
Within	10 100%	50 500%	10 100%	48 96%	9 18%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	9 90%	48 480%	10 100%	48 96%	10 20%	48 96%
Above	1 10%	2 20%	0 0%	1 2%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	1 10%	0 0%	0 0%	1 2%	0 0%	1 2%
Within	9 90%	49 490%	10 100%	48 96%	10 20%	47 94%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	1 2%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	50 500%	10 100%	48 96%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Below	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	10 100%	48 96%	10 20%	48 96%
Above	0 0%	1 10%	0 0%	1 2%	0 0%	1 2%

9. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Description	The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Time Frame	At Month 6

Outcome Measure Data

Analysis Population Description
The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	50	10	50	10	50
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	1 10%	0 0%	2 4%	0 0%	1 2%
Within	10 100%	48 480%	9 90%	47 94%	8 16%	47 94%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	8 80%	41 410%	7 70%	34 68%	6 12%	30 60%
Above	2 20%	8 80%	2 20%	15 30%	2 4%	18 36%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	9 90%	48 96%	8 16%	49 98%
Above	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	1 2%	1 2%
Within	10 100%	49 490%	9 90%	49 98%	7 14%	47 94%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	9 90%	49 98%	8 16%	47 94%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	1 10%	1 10%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	8 80%	44 88%	8 16%	44 88%
Above	0 0%	0 0%	0 0%	5 10%	0 0%	4 8%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	3 6%
Within	10 100%	49 490%	9 90%	48 96%	8 16%	45 90%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	9 90%	49 98%	8 16%	49 98%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	1 10%	1 10%	1 10%	2 4%	0 0%	2 4%
Within	9 90%	48 480%	8 80%	47 94%	8 16%	46 92%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Within	10 100%	49 490%	8 80%	48 96%	8 16%	46 92%
Above	0 0%	0 0%	1 10%	1 2%	0 0%	2 4%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	9 90%	49 98%	8 16%	49 98%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	1 2%
Below	0 0%	1 10%	0 0%	0 0%	1 2%	0 0%
Within	10 100%	46 460%	9 90%	49 98%	7 14%	48 96%
Above	0 0%	2 20%	0 0%	0 0%	0 0%	1 2%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	1 10%	0 0%	6 12%	0 0%	4 8%
Within	10 100%	48 480%	8 80%	43 86%	8 16%	44 88%
Above	0 0%	0 0%	1 10%	0 0%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	9 90%	49 98%	8 16%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	9 90%	46 460%	8 80%	42 84%	8 16%	48 96%
Above	1 10%	3 30%	1 10%	7 14%	0 0%	0 0%
Unknwon	0 0%	1 10%	1 10%	1 2%	2 4%	2 4%
Below	1 10%	2 20%	0 0%	7 14%	0 0%	3 6%
Within	9 90%	47 470%	9 90%	42 84%	8 16%	42 84%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	3 6%

10. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Description	The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Time Frame	At Month 9

Outcome Measure Data

Analysis Population Description
The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	50	10	50	10	50
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	1 10%	0 0%	0 0%	0 0%	3 6%
Within	10 100%	47 470%	10 100%	50 100%	9 18%	45 90%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Within	8 80%	32 320%	8 80%	38 76%	6 12%	35 70%
Above	2 20%	17 170%	2 20%	11 22%	3 6%	13 26%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	10 100%	50 100%	9 18%	46 92%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	2 4%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	9 90%	46 460%	10 100%	48 96%	9 18%	48 96%
Above	1 10%	3 30%	0 0%	2 4%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Within	10 100%	49 490%	10 100%	50 100%	9 18%	46 92%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	1 10%	1 10%	3 6%	0 0%	3 6%
Within	9 90%	46 460%	9 90%	47 94%	9 18%	44 88%
Above	1 10%	2 20%	0 0%	0 0%	0 0%	1 2%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	9 90%	48 480%	10 100%	50 100%	9 18%	48 96%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	10 100%	49 98%	8 16%	47 94%
Above	0 0%	0 0%	0 0%	1 2%	1 2%	1 2%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	3 30%	0 0%	0 0%	0 0%	3 6%
Within	10 100%	46 460%	10 100%	50 100%	9 18%	45 90%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	3 6%
Within	10 100%	48 480%	10 100%	50 100%	9 18%	45 90%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	48 480%	10 100%	50 100%	9 18%	46 92%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	2 4%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Within	10 100%	48 480%	10 100%	49 98%	9 18%	45 90%
Above	0 0%	1 10%	0 0%	0 0%	0 0%	2 4%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	2 20%	2 20%	0 0%	2 4%	0 0%	1 2%
Within	8 80%	46 460%	10 100%	46 92%	9 18%	47 94%
Above	0 0%	1 10%	0 0%	2 4%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	10 100%	49 490%	10 100%	50 100%	9 18%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Within	8 80%	45 450%	10 100%	46 92%	9 18%	48 96%
Above	2 20%	4 40%	0 0%	4 8%	0 0%	0 0%
Unknown	0 0%	1 10%	0 0%	0 0%	1 2%	2 4%
Below	0 0%	3 30%	0 0%	2 4%	0 0%	3 6%
Within	10 100%	46 460%	9 90%	47 94%	9 18%	43 86%
Above	0 0%	0 0%	1 10%	1 2%	0 0%	2 4%

11. Primary Outcome

Title	Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Description	The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description
The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccination administration documented for whom data were available and who had their symptom sheets filled in.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	10	50	10	50	10	50
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	2 20%	1 10%	2 4%	0 0%	0 0%
Whitin	10 100%	47 470%	8 80%	47 94%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%
Whitin	8 80%	45 450%	6 60%	38 76%	8 16%	41 82%
Above	2 20%	4 40%	3 30%	10 20%	2 4%	8 16%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Whitin	10 100%	45 450%	9 90%	44 88%	10 20%	49 98%
Above	0 0%	4 40%	0 0%	5 10%	0 0%	0 0%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	1 10%	1 10%	0 0%	1 2%	1 2%	0 0%
Whitin	9 90%	48 480%	9 90%	48 96%	9 18%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	1 2%	0 0%	1 2%
Whitin	10 100%	49 490%	9 90%	48 96%	10 20%	47 94%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	3 30%	1 10%	0 0%	0 0%	2 4%
Whitin	10 100%	43 430%	7 70%	43 86%	10 20%	45 90%
Above	0 0%	3 30%	1 10%	6 12%	0 0%	2 4%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%
Whitin	9 90%	49 490%	9 90%	49 98%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Whitin	10 100%	46 460%	7 70%	49 98%	10 20%	48 96%
Above	0 0%	3 30%	2 20%	0 0%	0 0%	1 2%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%
Whitin	10 100%	49 490%	9 90%	49 98%	10 20%	48 96%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	1 10%	0 0%	0 0%	1 2%	0 0%	0 0%
Whitin	9 90%	46 460%	9 90%	48 96%	10 20%	49 98%
Above	0 0%	3 30%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Whitin	10 100%	49 490%	8 80%	48 96%	9 18%	48 96%
Above	0 0%	0 0%	1 10%	1 2%	1 2%	1 2%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	2 20%	0 0%	0 0%	0 0%	0 0%
Whitin	10 100%	47 470%	8 80%	47 94%	9 18%	47 94%
Above	0 0%	0 0%	1 10%	2 4%	1 2%	2 4%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	1 10%	5 50%	1 10%	7 14%	0 0%	2 4%
Whitin	9 90%	41 410%	8 80%	42 84%	10 20%	46 92%
Above	0 0%	3 30%	0 0%	0 0%	0 0%	1 2%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Whitin	10 100%	49 490%	9 90%	49 98%	10 20%	49 98%
Above	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Whitin	8 80%	46 460%	8 80%	46 92%	10 20%	47 94%
Above	2 20%	3 30%	1 10%	3 6%	0 0%	2 4%
Unknown	0 0%	1 10%	1 10%	1 2%	0 0%	1 2%
Below	2 20%	2 20%	0 0%	3 6%	0 0%	6 12%
Whitin	8 80%	45 450%	9 90%	46 92%	10 20%	43 86%
Above	0 0%	2 20%	0 0%	0 0%	0 0%	0 0%

12. Primary Outcome

Title	Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens
Description	Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.
Time Frame	At Day 44

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	8	9	9	46	40	35
At least 1 antigen	1 10%	2 20%	2 20%	46 92%	40 80%	35 70%
At least 2 antigens	0 0%	1 10%	2 20%	46 92%	38 76%	34 68%
At least 3 antigens	0 0%	1 10%	0 0%	46 92%	34 68%	31 62%
All 4 antigens	0 0%	0 0%	0 0%	37 74%	22 44%	23 46%

13. Secondary Outcome

Title	Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Description	Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Time Frame	At Month 0, Day 44, Month 2, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	9	9	9	46	40	35
p17, Day 0	32.56 (46.31)	16.78 (16.08)	7.89 (10.86)	17.95 (25.64)	21.90 (44.84)	30.60 (49.28)
p17, Day 44	58.25 (67.23)	102.00 (171.17)	57.22 (76.97)	1724.07 (1335.80)	696.78 (592.73)	740.91 (637.48)
p17, Month 2	17.33 (28.18)	60.11 (79.90)	30.22 (40.38)	1238.82 (968.59)	517.38 (440.05)	625.88 (525.66)
p17, Month 6	22.22 (28.83)	80.50 (119.81)	61.63 (74.83)	762.59 (608.13)	376.80 (291.36)	360.32 (324.15)
p17, Month 12	28.50 (42.64)	70.13 (140.50)	25.00 (28.14)	766.55 (620.56)	345.55 (320.76)	462.29 (439.06)
p24, Day 0	51.67 (55.49)	27.56 (48.52)	29.11 (43.11)	30.60 (41.68)	54.95 (68.53)	52.14 (80.65)
p24, Day 44	47.25 (38.39)	205.22 (375.13)	119.22 (160.14)	3078.59 (1694.26)	1441.93 (1286.57)	1446.17 (990.24)
p24, Month 2	31.56 (58.84)	142.67 (138.05)	87.22 (83.82)	2228.00 (1255.40)	1171.50 (1220.16)	1120.58 (654.53)
p24, Month 6	53.78 (85.56)	83.75 (122.43)	143.63 (130.22)	1320.63 (1002.27)	775.63 (588.91)	562.26 (402.53)
p24, Month 12	34.25 (38.37)	74.00 (77.45)	101.78 (108.18)	1282.00 (819.01)	766.55 (549.94)	718.17 (533.47)
Nef, Day 0	25.78 (45.94)	22.00 (40.81)	78.11 (98.18)	40.02 (49.98)	39.53 (59.12)	58.97 (101.11)
Nef, Day 44	52.63 (65.28)	89.00 (81.17)	108.22 (97.17)	1822.50 (1553.80)	872.83 (706.00)	862.20 (721.64)
Nef, Month 2	30.56 (55.59)	75.67 (104.05)	73.00 (93.10)	1307.89 (1080.10)	678.78 (503.13)	713.33 (490.14)
Nef, Month 6	46.67 (70.30)	36.25 (56.89)	38.75 (40.15)	855.13 (901.48)	532.80 (508.78)	374.32 (302.71)
Nef, Month 12	23.00 (36.26)	20.75 (47.65)	42.56 (66.95)	722.80 (780.58)	404.98 (364.64)	426.34 (447.54)
RT, Day 0	77.44 (83.84)	31.67 (44.13)	21.33 (27.16)	52.53 (109.33)	52.85 (96.57)	63.80 (74.44)
RT, Day 44	107.75 (115.20)	250.00 (351.18)	262.00 (327.68)	6760.11 (3832.30)	2787.43 (1785.69)	2518.71 (1389.15)
RT, Month 2	109.22 (67.04)	242.22 (349.31)	209.89 (363.37)	4731.64 (2761.73)	2304.75 (1798.00)	2107.61 (1107.18)
RT, Month 6	46.67 (61.07)	140.75 (210.46)	103.88 (165.37)	3157.02 (2345.20)	1539.85 (1100.27)	1198.74 (748.47)
RT, Month 12	54.50 (59.96)	99.38 (106.52)	132.33 (216.98)	2965.34 (2148.86)	1433.63 (1020.80)	1347.26 (988.06)

14. Secondary Outcome

Title	Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Description	Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Time Frame	At Month 0, Day 44, Month 2, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	9	9	9	46	40	35
p17, Day 0	21.89 (30.92)	5.56 (10.45)	30.44 (63.90)	23.58 (34.72)	32.75 (62.91)	39.80 (65.83)
p17, Day 44	59.75 (76.90)	104.22 (146.67)	69.67 (84.30)	1937.11 (1457.55)	777.68 (662.55)	850.86 (724.32)
p17, Month 2	15.11 (24.79)	65.56 (84.74)	23.00 (30.72)	1308.50 (1000.94)	562.63 (473.95)	682.70 (553.88)
p17, Month 6	57.78 (72.39)	101.38 (132.38)	94.13 (112.30)	791.54 (636.43)	411.95 (290.81)	398.62 (348.32)
p17, Month 12	32.13 (45.05)	101.25 (197.89)	31.00 (36.44)	784.57 (613.62)	374.65 (319.92)	501.60 (451.23)
p24, Day 0	46.67 (51.44)	46.56 (78.36)	93.56 (155.14)	60.05 (67.01)	77.98 (87.63)	68.31 (100.00)
p24, Day 44	80.13 (47.22)	243.00 (441.48)	161.56 (161.44)	3536.04 (1850.10)	1662.85 (1462.02)	1661.03 (1108.49)
p24, Month 2	49.11 (83.84)	145.56 (179.74)	121.89 (152.43)	2429.89 (1309.28)	1306.25 (1320.29)	1253.06 (685.13)
p24, Month 6	53.78 (53.78)	83.75 (122.43)	143.63 (130.22)	1320.63 (1002.27)	775.63 (588.91)	562.26 (402.53)
p24, Month 12	34.25 (38.37)	74.00 (77.45)	101.78 (108.18)	1282.00 (819.01)	766.55 (549.94)	718.17 (533.47)
Nef, Day 0	18.67 (36.54)	30.00 (57.59)	157.56 (206.05)	52.74 (64.54)	60.70 (91.26)	80.51 (126.89)
Nef, Day 44	61.00 (77.57)	87.11 (64.23)	138.44 (123.44)	2133.76 (1825.49)	1039.80 (830.73)	1034.77 (836.85)
Nef, Month 2	51.78 (82.87)	69.89 (143.34)	99.78 (123.76)	1470.00 (1160.99)	751.35 (521.38)	826.45 (539.88)
Nef, Month 6	66.67 (64.44)	29.75 (46.20)	73.75 (55.65)	906.78 (935.03)	574.18 (536.34)	435.71 (293.58)
Nef, Month 12	60.50 (61.35)	45.63 (50.45)	50.44 (54.97)	786.23 (803.67)	432.85 (379.08)	485.23 (478.78)
RT, Day 0	158.56 (363.46)	60.78 (71.21)	47.22 (44.13)	107.84 (225.52)	81.00 (143.07)	148.37 (346.73)
RT, Day 44	328.25 (556.42)	311.00 (352.09)	297.78 (368.77)	7843.87 (4284.29)	3231.88 (2077.15)	3041.74 (1961.13)
RT, Month 2	365.00 (729.94)	261.78 (385.82)	283.56 (380.40)	5291.91 (2921.62)	2575.98 (1972.59)	2471.94 (1509.43)
RT, Month 6	46.67 (61.07)	140.75 (210.46)	103.88 (165.37)	3157.02 (2345.20)	1539.85 (1100.27)	1198.74 (748.47)
RT, Month 12	54.50 (59.96)	99.38 (106.52)	132.33 (216.98)	2965.34 (2148.86)	1433.63 (1020.80)	1347.26 (988.06)

15. Secondary Outcome

Title	Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Description	Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs).
Time Frame	At Month 0, Day 44, Month 2, Month 6 and Month 12

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	SB732461 Non-adjuvanted_LD Group	SB732461 Non-adjuvanted_MD Group	SB732461 Non-adjuvanted_HD Group	SB732461 adjuvanted_LD Group	SB732461 adjuvanted_MD Group	SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
Measure Participants	9	9	9	49	41	35
Anti-p17, Day 0	93.5	109.5	93.5	93.5	93.5	96.3
Anti-p17, Day 44	93.5	133.3	104.2	824.9	1416.4	1499.7
Anti-p17, Month 2	93.5	107.6	93.5	553.2	808.2	1189.3
Anti-p17, Month 6	93.5	93.5	93.5	169.0	167.4	146.6
Anti-p17, Month 12	93.5	93.5	93.5	128.0	140.5	133.7
Anti-p24, Day 0	59.5	64.7	59.5	59.5	59.5	62.1
Anti-p24, Day 44	65.3	120.3	88.8	18765.3	18788.8	21089.3
Anti-p24, Month 2	69.7	97.5	87.4	12453.4	11238.4	12541.9
Anti-p24, Month 6	59.5	59.5	83.0	2800.2	1898.0	2082.9
Anti-p24, Month 12	59.5	59.5	70.8	1254.8	840.6	762.6
Anti-Nef, Day 0	116.0	138.0	116.0	120.0	129.6	136.1
Anti-Nef, Day 44	157.8	229.2	184.6	27263.0	20504.6	26844.9
Anti-Nef, Month 2	152.1	185.3	168.4	12467.6	12378.1	17926.2
Anti-Nef, Month 6	144.9	135.4	173.8	2133.7	1617.1	2712.2
Anti-Nef, Month 12	135.9	154.2	116.0	1032.4	710.4	1330.2
Anti-RT, Day 0	62.5	62.5	69.1	62.5	64.2	62.5
Anti-RT, Day 44	62.5	95.5	100.1	8979.1	10019.9	11812.0
Anti-RT, Month 2	76.7	85.6	96.5	5761.6	6543.3	6959.8
Anti-RT, Month 6	71.4	75.7	62.5	705.5	902.5	883.9
Anti-RT, Month 12	74.3	62.5	72.0	462.1	428.7	471.1
Anti-F4co, Month 0	21.0	24.6	21.0	21.0	21.0	21.5
Anti-F4co, Day 44	23.8	42.1	42.7	7027.2	11151.6	12359.6
Anti-F4co, Month 2	26.1	34.7	31.5	4770.3	4607.8	5438.7
Anti-F4co, Month 6	22.9	25.5	31.0	1303.1	1081.4	1081.4
Anti-F4co, Month 12	25.1	23.6	33.1	790.7	1154.0	837.5

Adverse Events

	SB732461 Non-adjuvanted_LD Group		SB732461 Non-adjuvanted_MD Group		SB732461 Non-adjuvanted_HD Group		SB732461 adjuvanted_LD Group		SB732461 adjuvanted_MD Group		SB732461 adjuvanted_HD Group
Time Frame	Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
Adverse Event Reporting Description

Arm/Group Title	SB732461 Non-adjuvanted_LD Group		SB732461 Non-adjuvanted_MD Group		SB732461 Non-adjuvanted_HD Group		SB732461 adjuvanted_LD Group		SB732461 adjuvanted_MD Group		SB732461 adjuvanted_HD Group
Arm/Group Description	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.		Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.		Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.		Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.		Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.		Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/50 (0%)		0/50 (0%)		0/50 (0%)
Serious Adverse Events
	SB732461 Non-adjuvanted_LD Group		SB732461 Non-adjuvanted_MD Group		SB732461 Non-adjuvanted_HD Group		SB732461 adjuvanted_LD Group		SB732461 adjuvanted_MD Group		SB732461 adjuvanted_HD Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		2/50 (4%)		2/50 (4%)		2/50 (4%)
Infections and infestations
Appendicitis perforated	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	1/50 (2%)	1
Tonsillitis	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/50 (2%)	1	0/50 (0%)	0	0/50 (0%)	0
Injury, poisoning and procedural complications
Brain contusion	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	1/50 (2%)	1	0/50 (0%)	0
Ligament rupture	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/50 (2%)	1	0/50 (0%)	0	0/50 (0%)	0
Skin and subcutaneous tissue disorders
Henoch-schonlein purpura	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	1/50 (2%)	1
Urticaria	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	1/50 (2%)	1	0/50 (0%)	0
Other (Not Including Serious) Adverse Events
	SB732461 Non-adjuvanted_LD Group		SB732461 Non-adjuvanted_MD Group		SB732461 Non-adjuvanted_HD Group		SB732461 adjuvanted_LD Group		SB732461 adjuvanted_MD Group		SB732461 adjuvanted_HD Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/10 (80%)		7/10 (70%)		9/10 (90%)		50/50 (100%)		50/50 (100%)		50/50 (100%)
Gastrointestinal disorders
Diarrhoea	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/50 (0%)	0	2/50 (4%)	2	1/50 (2%)	1
Gastrointestinal disorder	2/10 (20%)	2	2/10 (20%)	2	2/10 (20%)	3	23/50 (46%)	29	21/50 (42%)	24	17/50 (34%)	21
Toothache	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	1/50 (2%)	1
Vomiting	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	3/50 (6%)	3
General disorders
Axillary pain	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	3/50 (6%)	4	0/50 (0%)	0
Chills	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	9/50 (18%)	11	0/50 (0%)	0	3/50 (6%)	3
Fatigue	5/10 (50%)	6	5/10 (50%)	7	6/10 (60%)	9	41/50 (82%)	67	47/50 (94%)	71	46/50 (92%)	77
Hangover	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Influenza like illness	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	4/50 (8%)	4	3/50 (6%)	3	2/50 (4%)	2
Pain	3/10 (30%)	5	2/10 (20%)	2	5/10 (50%)	6	49/50 (98%)	96	50/50 (100%)	98	50/50 (100%)	97
Pyrexia	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	30/50 (60%)	34	29/50 (58%)	32	26/50 (52%)	29
Swelling	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	13/50 (26%)	20	18/50 (36%)	25	19/50 (38%)	22
Infections and infestations
Acute sinusitis	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Nasopharyngitis	2/10 (20%)	2	0/10 (0%)	0	0/10 (0%)	0	3/50 (6%)	3	0/50 (0%)	0	0/50 (0%)	0
Oral herpes	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Pharyngitis	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/50 (2%)	1	1/50 (2%)	1	1/50 (2%)	1
Rhinitis	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/50 (0%)	0	1/50 (2%)	1	3/50 (6%)	3
Tooth abscess	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Upper respiratory tract infection	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	5/50 (10%)	5	1/50 (2%)	1	3/50 (6%)	3
Metabolism and nutrition disorders
Iron deficiency	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/50 (2%)	1	1/50 (2%)	1	1/50 (2%)	1
Musculoskeletal stiffness	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	3/50 (6%)	4	5/50 (10%)	6	6/50 (12%)	6
Myalgia	2/10 (20%)	2	1/10 (10%)	2	2/10 (20%)	2	31/50 (62%)	45	35/50 (70%)	52	36/50 (72%)	52
Neck pain	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	3/50 (6%)	4	1/50 (2%)	2	0/50 (0%)	0
Nervous system disorders
Dizziness	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/50 (2%)	1	2/50 (4%)	3	3/50 (6%)	3
Headache	5/10 (50%)	5	4/10 (40%)	8	5/10 (50%)	5	43/50 (86%)	78	42/50 (84%)	65	41/50 (82%)	65
Syncope	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Tension headache	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Psychiatric disorders
Stress	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/50 (2%)	1	0/50 (0%)	0	0/50 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	2/10 (20%)	2	0/10 (0%)	0	0/10 (0%)	0	4/50 (8%)	4	4/50 (8%)	4	3/50 (6%)	4
Productive cough	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/50 (2%)	1	0/50 (0%)	0	3/50 (6%)	4
Skin and subcutaneous tissue disorders
Ecchymosis	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/50 (0%)	0	0/50 (0%)	0	0/50 (0%)	0
Erythema	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	14/50 (28%)	19	23/50 (46%)	35	25/50 (50%)	34
Hyperhidrosis	1/10 (10%)	1	1/10 (10%)	1	3/10 (30%)	3	28/50 (56%)	35	28/50 (56%)	33	26/50 (52%)	34

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.

Results Point of Contact

Name/Title	GSK Response Center
Organization	GlaxoSmithKline
Phone	866-435-7343
Email

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00434512

Other Study ID Numbers:

108706
2006-003796-12

First Posted:

Feb 13, 2007

Last Update Posted:

Oct 1, 2019

Last Verified:

Sep 1, 2019

Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact