HVTN119: Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT03181789
• Collaborator: (none)
• Enrollment: 56
• Locations: 3
• Arms: 4
• Actual Duration (Months): 30.4
• Patients Per Site: 18.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: p24CE1/2 pDNA Vaccine; Biological: p55^gag pDNA Vaccine; Biological: IL-12 pDNA Adjuvant; Biological: Placebo; Device: Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device	Phase 1

Detailed Description

This study will evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.

Participants will be randomly assigned to one of four groups: Group 1 Treatment, Group 1 Control, Group 2 Treatment, or Group 2 Control.

Participants in Group 1 Treatment will receive p24CE1/2 pDNA and IL-12 pDNA at Day 0 and Month 1, then p24CE1/2 pDNA plus p55^gag pDNA and IL-12 pDNA at Months 3 and 6. Participants in Group 1 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6.

Participants in Group 2 Treatment will receive p55^gag pDNA and IL-12 pDNA at Day 0 and Months 1, 3, and 6. Participants in Group 2 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6.

Study visits will occur at Day 0, Week 2, and Months 1, 1.25, 1.5, 3, 3.5, 6, 6.25, 6.5, 9, and 12. Visits may include physical examinations and clinical assessments, blood and urine collection, optional stool collection, HIV testing, risk reduction counseling, and interviews/questionnaires. At Month 18, study staff will contact participants for follow-up health monitoring.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA, in Healthy, HIV-Uninfected Adult Participants
• Actual Study Start Date: Oct 18, 2017
• Actual Primary Completion Date: Oct 25, 2019
• Actual Study Completion Date: Apr 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 (Treatment): p24CE1/2 pDNA + p55^gag pDNA + IL-12 pDNA Participants will receive the p24CE1/2 pDNA vaccine and the IL-12 pDNA adjuvant at Day 0 and Month 1. They will receive the p24CE1/2 pDNA vaccine plus the p55^gag pDNA vaccine and the IL-12 pDNA adjuvant at Months 3 and 6.	Biological: p24CE1/2 pDNA Vaccine; Administered bilaterally using the Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device; Other Names: p24CE1/2 ; Biological: p55^gag pDNA Vaccine; Administered bilaterally using the TDS-IM EP device; Other Names: p55^gag ; Biological: IL-12 pDNA Adjuvant; Administered bilaterally using the TDS-IM EP device; Other Names: GENEVAX® IL-12 DNA Plasmid ; Device: Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device; The TDS-IM EP device will be used to administer study product(s).; Other Names: TDS-IM EP device
Placebo Comparator: Group 1 (Control): Placebo Participants will receive placebo at Day 0 and Months 1, 3, and 6.	Biological: Placebo; Administered bilaterally using the TDS-IM EP device; Device: Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device; The TDS-IM EP device will be used to administer study product(s).; Other Names: TDS-IM EP device
Experimental: Group 2 (Treatment): p55^gag pDNA + IL-12 pDNA Participants will receive the p55^gag pDNA vaccine and the IL-12 pDNA adjuvant at Day 0 and Months 1, 3, and 6.	Biological: p55^gag pDNA Vaccine; Administered bilaterally using the TDS-IM EP device; Other Names: p55^gag ; Biological: IL-12 pDNA Adjuvant; Administered bilaterally using the TDS-IM EP device; Other Names: GENEVAX® IL-12 DNA Plasmid ; Device: Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device; The TDS-IM EP device will be used to administer study product(s).; Other Names: TDS-IM EP device
Placebo Comparator: Group 2 (Control): Placebo Participants will receive placebo at Day 0 and Months 1, 3, and 6.	Biological: Placebo; Administered bilaterally using the TDS-IM EP device; Device: Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device; The TDS-IM EP device will be used to administer study product(s).; Other Names: TDS-IM EP device

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness [Measured through Month 0, 1, 3, 6]

   Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove

2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration [Measured through Month 0, 1, 3, 6]

   Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove

3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms [Measured through Month 0, 1, 3, 6]

   Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove

4. Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L [Measured during screening, Days 14, 42, 98, 182 and 273]

   For each local laboratory measure-alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK) in U/L, summary statistics were presented by treatment group and timepoint for the overall population.

5. Chemistry and Hematology Laboratory Measures - Creatinine in g/dL [Measured during screening, Days 14, 42, 98, 182 and 273]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population

6. Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL [Measured during screening, Days 14, 42, 98, 182 and 273]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

7. Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 [Measured during screening, Days 14, 42, 98, 175 and 273]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

8. Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 [Measured during screening, Days 14, 42, 98, 175 and 273]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

9. Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 [Measured during screening, Days 14, 42, 98, 182 and 273 for (ALP), (AST), (ALT), (CPK), creatinine. Measured during screening, Days 14, 42, 98, 175, 182 and 273 for Lymphocyte count, Neutrophil count Platelets, WBC, hemoglobin.]

   The number (percentage) of participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment group and visit time

10. Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation [Measured through Month 18]

    The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm

11. Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) [Measured during Day 0, 28, 84 and 168]

    A visual analog scale is a horizontal line, 10 cm in length, anchored by word descriptors at each end ("no pain" and "worst pain"). The visual analog scale score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks, 0 cm being no pain and 10 cm being maximum pain.The pain assessment scores for each arm at each vaccination visit were summarized with visual analog scale (VAS)

12. Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] [Measured during Visit 3 (Day14), Visit 5 (Day 35), Visit 8 (Day 98), Visit 10 (Day 175)]

    Distribution of responses to questions regarding acceptability of study injection procedures [ Visits 3, 5, 8, 10] were summarized by category (Acceptable/Unacceptable/Don?t know/ Don?t Remember)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

General and Demographic Criteria

• Age of 18 to 50 years

• Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study

• Agrees not to enroll in another study of an investigational research agent prior to completion of last required protocol visit (excludes annual health contact visit)

• Good general health as shown by medical history, physical exam, and screening laboratory tests

HIV-Related Criteria:

• Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.

Laboratory Inclusion Values

• Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male

• White blood cell count equal to 3,300 to 12,000 cells/mm^3

• Total lymphocyte count greater than or equal to 800 cells/mm^3

• Remaining differential either within institutional normal range or with site physician approval

• Platelets equal to 125,000 to 550,000/mm^3

• Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatine phosphokinase (CPK) less than or equal to 2.0 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal.

Virology

• Negative HIV-1 and -2 blood test: U.S. volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA).

• Negative Hepatitis B surface antigen (HBsAg)

• Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive

• Normal urine:

• Negative urine glucose, and

• Negative or trace urine protein, and

• Negative or trace urine hemoglobin

Reproductive Status

• Reproductive status: A volunteer who was born female must:

• Agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit.

• Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;

• Or be sexually abstinent.

Exclusion Criteria:

General

• Allergy to amide-type local anesthetics (bupivacaine [Marcaine], lidocaine [Xylocaine], mepivacaine [Polocaine/Carbocaine], etidocaine [Duranest], prilocaine [Citanest, EMLA® cream])

• Investigational research agents received within 30 days before first vaccination

• Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia

• Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the study

• Pregnant or breastfeeding

• Active duty and reserve U.S. military personnel

Vaccines and other Injections

• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis.

• Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 119 PSRT will determine eligibility on a case-by-case basis.

• Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial.

Immune System

• Immunosuppressive medications received within 168 days before first vaccination.

• Serious adverse reactions to vaccines or to vaccine components

• Autoimmune disease

• Immunodeficiency

Clinically significant medical conditions

• Untreated or incompletely treated syphilis infection

• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health.

• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent

• Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.

• Current anti-tuberculosis (TB) prophylaxis or therapy

• Asthma exclusion criteria: Asthma other than mild, well-controlled asthma.

• Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)

• Thyroidectomy, or thyroid disease requiring medication during the last 12 months

• Hypertension

• Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)

• Malignancy

• Seizure disorder

• Asplenia

• History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.

• Presence of implanted electronic medical device (e.g., cochlear implant, pacemaker, implantable cardioverter defibrillator)

• Presence of surgical or traumatic metal implant at the intended site of administration (including the deltoid muscles and/or overlying skin)

• Sinus bradycardia (defined as less than 50 beats per minute (bpm) on exam) or a history of cardiac arrhythmia: e.g., supraventricular tachycardia, atrial fibrillation, or frequent ectopy. NOTE: Sinus arrhythmia is not excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bridge HIV CRS	San Francisco	California	United States	94143
2	The Hope Clinic of the Emory Vaccine Center CRS	Decatur	Georgia	United States	30030
3	Case Clinical Research Site	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Spyros Kalams, Vanderbilt University
• Study Chair: Hyman Scott, Bridge HIV, SFDPH

Study Documents (Full-Text)

• Study Protocol - Feb 17, 2017
• Statistical Analysis Plan - Aug 17, 2020

More Information

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT03181789
• Other Study ID Numbers: HVTN 119; 12061
• First Posted: Jun 9, 2017
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): HIV vaccine; DNA vaccine; IL-12; Electroporation; p24; Gag; Adjuvant; Healthy
• Additional relevant MeSH terms: HIV Infections; Interleukin-12; Vaccines

Study Results

Participant Flow

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Period Title: Overall Study
STARTED	25	25	3	3
Safety Population	25	25	3	3
COMPLETED	18	22	2	3
NOT COMPLETED	7	3	1	0

Baseline Characteristics

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2	Total
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%	Total of all reporting groups
Overall Participants	25	25	3	3	56
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	29	31	24	30	29
Age, Customized (Count of Participants)
Less than 18	0 0%	0 0%	0 0%	0 0%	0 0%
18 - 20	1 4%	1 4%	0 0%	0 0%	2 3.6%
21 - 30	13 52%	11 44%	2 66.7%	2 66.7%	28 50%
31 - 40	3 12%	9 36%	0 0%	1 33.3%	13 23.2%
41 - 50	8 32%	4 16%	1 33.3%	0 0%	13 23.2%
Over 50	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 48%	15 60%	3 100%	3 100%	33 58.9%
Male	13 52%	10 40%	0 0%	0 0%	23 41.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4%	3 12%	1 33.3%	0 0%	5 8.9%
Not Hispanic or Latino	24 96%	22 88%	2 66.7%	3 100%	51 91.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 4%	0 0%	0 0%	1 1.8%
Asian	0 0%	2 8%	0 0%	0 0%	2 3.6%
Native Hawaiian or Other Pacific Islander	1 4%	0 0%	0 0%	0 0%	1 1.8%
Black or African American	4 16%	6 24%	0 0%	0 0%	10 17.9%
White	16 64%	11 44%	3 100%	3 100%	33 58.9%
More than one race	2 8%	2 8%	0 0%	0 0%	4 7.1%
Unknown or Not Reported	2 8%	3 12%	0 0%	0 0%	5 8.9%
Region of Enrollment (Count of Participants)
United States	25 100%	25 100%	3 100%	3 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Description	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Time Frame	Measured through Month 0, 1, 3, 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
None	4 16%	1 4%	0 0%	0 0%
Mild	13 52%	21 84%	2 66.7%	3 100%
Moderate	8 32%	3 12%	1 33.3%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	0 0%	0 0%	0 0%	0 0%
Mild	17 68%	18 72%	1 33.3%	2 66.7%
Moderate	8 32%	7 28%	2 66.7%	1 33.3%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	0 0%	0 0%	0 0%	0 0%
Mild	15 60%	18 72%	1 33.3%	2 66.7%
Moderate	10 40%	7 28%	2 66.7%	1 33.3%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Description	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Time Frame	Measured through Month 0, 1, 3, 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
None	23 92%	21 84%	2 66.7%	2 66.7%
Mild	2 8%	3 12%	1 33.3%	1 33.3%
Moderate	0 0%	1 4%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	23 92%	22 88%	3 100%	3 100%
Mild	1 4%	2 8%	0 0%	0 0%
Moderate	1 4%	1 4%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	22 88%	20 80%	2 66.7%	2 66.7%
Mild	2 8%	4 16%	1 33.3%	1 33.3%
Moderate	1 4%	1 4%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Description	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Time Frame	Measured through Month 0, 1, 3, 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
None	10 40%	6 24%	2 66.7%	0 0%
Mild	11 44%	14 56%	1 33.3%	1 33.3%
Moderate	3 12%	4 16%	0 0%	2 66.7%
Severe	1 4%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	13 52%	15 60%	0 0%	0 0%
Mild	9 36%	8 32%	3 100%	2 66.7%
Moderate	3 12%	1 4%	0 0%	1 33.3%
Severe	0 0%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	14 56%	11 44%	2 66.7%	1 33.3%
Mild	9 36%	6 24%	1 33.3%	1 33.3%
Moderate	2 8%	7 28%	0 0%	1 33.3%
Severe	0 0%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	18 72%	18 72%	3 100%	2 66.7%
Mild	6 24%	5 20%	0 0%	1 33.3%
Moderate	1 4%	1 4%	0 0%	0 0%
Severe	0 0%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	25 100%	24 96%	3 100%	3 100%
Mild	0 0%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	24 96%	22 88%	3 100%	1 33.3%
Mild	1 4%	1 4%	0 0%	0 0%
Moderate	0 0%	1 4%	0 0%	2 66.7%
Severe	0 0%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	19 76%	21 84%	2 66.7%	1 33.3%
Mild	5 20%	2 8%	1 33.3%	1 33.3%
Moderate	1 4%	1 4%	0 0%	1 33.3%
Severe	0 0%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	4 16%	3 12%	0 0%	0 0%
Mild	14 56%	12 48%	3 100%	1 33.3%
Moderate	6 24%	9 36%	0 0%	2 66.7%
Severe	1 4%	1 4%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	23 92%	25 100%	3 100%	3 100%
Mild	2 8%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
Description	For each local laboratory measure-alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK) in U/L, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 42, 98, 182 and 273

Outcome Measure Data

Analysis Population Description

The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
ALT (SGPT) (U/L)- Screening	17	16	12	16
ALT (SGPT) (U/L)-Day 14	14.5	16.5	9	12
ALT (SGPT) (U/L)-Day 42	14.5	15	12	17
ALT (SGPT) (U/L)-Day 98	15	13	11	16
ALT (SGPT) (U/L)-Day 182	16	17	13	13.5
ALT (SGPT) (U/L)-Day 273	16	15.5	11	12
AST (U/L)- Screening	17	17	18	15
AST (U/L)-Day 14	16	17	13.5	13
AST (U/L)-Day 42	16	16	14	24
AST (U/L)-Day 98	17	16	15	18
AST (U/L)-Day 182	18	20	17	18
AST (U/L)-Day 273	16	18	15.5	15
Alkaline Phosphatase (U/L)- Screening	61	61	52	54
Alkaline Phosphatase (U/L)-Day 14	61	57.5	52	48
Alkaline Phosphatase (U/L)-Day 42	55.5	61	51	50
Alkaline Phosphatase (U/L)-Day 98	54	55	51	52
Alkaline Phosphatase (U/L)-Day 182	59	56	55	61.5
Alkaline Phosphatase (U/L)-Day 273	57	55	53.5	51
creatine phosphokinase (U/L)- Screening	94	92	88	88
creatine phosphokinase (U/L)-Day 14	113.5	92.5	58.5	116
creatine phosphokinase (U/L)-Day 42	118	91	77	222
creatine phosphokinase (U/L)-Day 98	110	102	63	157
creatine phosphokinase (U/L)-Day 182	121	99	79	133
creatine phosphokinase (U/L)-Day 273	123	98.5	54.5	111

5. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Time Frame	Measured during screening, Days 14, 42, 98, 182 and 273

Outcome Measure Data

Analysis Population Description

The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
Creatinine (g/dL)- Screening	0.00084	0.0008	0.00072	0.00093
Creatinine (g/dL)-Day 14	0.00086	0.00084	0.000645	0.00085
Creatinine (g/dL)-Day 42	0.00083	0.00085	0.00072	0.00089
Creatinine (g/dL)-Day 98	0.00085	0.00085	0.00065	0.00093
Creatinine (g/dL)-Day 182	0.00084	0.00085	0.00073	0.00081
Creatinine (g/dL)-Day 273	0.00088	0.00083	0.00073	0.00084

6. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 42, 98, 182 and 273

Outcome Measure Data

Analysis Population Description

The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
Hemoglobin (g/dL)- Screening	14.2	14.4	12.6	14.7
Hemoglobin (g/dL)-Day 14	13.8	13.95	13.35	13.9
Hemoglobin (g/dL)-Day 42	14.05	14	12.7	14.6
Hemoglobin (g/dL)-Day 98	14.25	13.95	12	14.6
Hemoglobin (g/dL)-Day 175	13.95	13.45	13.4	13.5
Hemoglobin (g/dL)-Day 182	12
Hemoglobin (g/dL)-Day 273	14	14	14	14.6

7. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 42, 98, 175 and 273

Outcome Measure Data

Analysis Population Description

The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
Neutrophils (1000*cells/mm^3)- Screening	3.621	3.564	3.16	3.306
Neutrophils (1000*cells/mm^3)-Day 14	3.5165	3.1235	5.1805	3.224
Neutrophils (1000*cells/mm^3)-Day 42	3.348	3.036	2.292	3.31
Neutrophils (1000*cells/mm^3)-Day 98	2.9925	3.0915	2.961	2.626
Neutrophils (1000*cells/mm^3)-Day 175	2.773	2.7645	2.902	4.694
Neutrophils (1000*cells/mm^3)-Day 182	3.018
Neutrophils (1000*cells/mm^3)-Day 273	3.279	3.011	6.428	2.677
Lymphocytes (1000*cells/mm^3)- Screening	1.916	1.765	1.84	1.928
Lymphocytes (1000*cells/mm^3)-Day 14	1.907	1.873	2.9485	1.712
Lymphocytes (1000*cells/mm^3)-Day 42	1.8925	1.88	2.35	2.037
Lymphocytes (1000*cells/mm^3)-Day 98	1.8265	1.668	2.13	2.15
Lymphocytes (1000*cells/mm^3)-Day 175	1.8365	1.846	1.42	1.855
Lymphocytes (1000*cells/mm^3)-Day 182	1.847
Lymphocytes (1000*cells/mm^3)-Day 273	1.717	1.701	1.76	2.328

8. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 42, 98, 175 and 273

Outcome Measure Data

Analysis Population Description

The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
WBC (1000*cells/mm^3)- Screening	6.2	6.4	7.9	5.7
WBC (1000*cells/mm^3)-Day 14	6.25	5.55	9.75	5.4
WBC (1000*cells/mm^3)-Day 42	6	6	8.1	5.9
WBC (1000*cells/mm^3)-Day 98	5.75	5.35	7	6.2
WBC (1000*cells/mm^3)-Day 175	5.3	5.1	5.9	7.2
WBC (1000*cells/mm^3)-Day 182	5.45
WBC (1000*cells/mm^3)-Day 273	5.9	5.55	8.9	4.9
Platelets (1000*cells/mm^3)- Screening	271	244	274	264
Platelets (1000*cells/mm^3)-Day 14	276.5	269	335	231
Platelets (1000*cells/mm^3)-Day 42	261.5	260	265	226
Platelets (1000*cells/mm^3)-Day 98	275	241	302	262
Platelets (1000*cells/mm^3)-Day 175	271	241.5	255	256
Platelets (1000*cells/mm^3)-Day 182	255.5
Platelets (1000*cells/mm^3)-Day 273	284	243.5	229.5	232

9. Primary Outcome

Title	Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Description	The number (percentage) of participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment group and visit time
Time Frame	Measured during screening, Days 14, 42, 98, 182 and 273 for (ALP), (AST), (ALT), (CPK), creatinine. Measured during screening, Days 14, 42, 98, 175, 182 and 273 for Lymphocyte count, Neutrophil count Platelets, WBC, hemoglobin.

Outcome Measure Data

Analysis Population Description

The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. Visit schedule is not the same for each laboratory measures. For visits not on the schedule, number analyzed is 0 or applicable participants number.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
WBC (1000*Cells/mm^3)- Screening	0 0%	0 0%	0 0%	0 0%
WBC (1000*Cells/mm^3)-Day 14	0 0%	0 0%	0 0%	0 0%
WBC (1000*Cells/mm^3)-Day 42	0 0%	0 0%	0 0%	0 0%
WBC (1000*Cells/mm^3)-Day 98	0 0%	0 0%	0 0%	0 0%
WBC (1000*Cells/mm^3)-Day 175	0 0%	0 0%	0 0%	0 0%
WBC (1000*Cells/mm^3)-Day 182	0 0%	0 0%	0 0%	0 0%
WBC (1000*Cells/mm^3)-Day 273	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000*Cells/mm^3)- Screening	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000*Cells/mm^3)-Day 14	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000*Cells/mm^3)-Day 42	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000*Cells/mm^3)-Day 98	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000*Cells/mm^3)-Day 175	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000*Cells/mm^3)-Day 182	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000*Cells/mm^3)-Day 273	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Screening	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 14	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 42	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 98	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 175	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 182	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 273	1 4%	0 0%	0 0%	0 0%
Lymphocytes (1000*Cells/mm^3)- Screening	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000*Cells/mm^3)-Day 14	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000*Cells/mm^3)-Day 42	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000*Cells/mm^3)-Day 98	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000*Cells/mm^3)-Day 175	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000*Cells/mm^3)-Day 182	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000*Cells/mm^3)-Day 273	0 0%	0 0%	0 0%	0 0%
Platelets (1000*Cells/mm^3)- Screening	0 0%	0 0%	0 0%	0 0%
Platelets (1000*Cells/mm^3)-Day 14	0 0%	0 0%	0 0%	0 0%
Platelets (1000*Cells/mm^3)-Day 42	0 0%	0 0%	0 0%	0 0%
Platelets (1000*Cells/mm^3)-Day 98	0 0%	0 0%	0 0%	0 0%
Platelets (1000*Cells/mm^3)-Day 175	0 0%	0 0%	0 0%	0 0%
Platelets (1000*Cells/mm^3)-Day 182	0 0%	0 0%	0 0%	0 0%
Platelets (1000*Cells/mm^3)-Day 273	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Screening	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)-Day 14	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)-Day 42	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)-Day 98	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)-Day 175	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)-Day 182	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)-Day 273	0 0%	0 0%	0 0%	0 0%
AST (U/L)- Screening	0 0%	0 0%	0 0%	0 0%
AST (U/L)-Day 14	0 0%	0 0%	0 0%	0 0%
AST (U/L)-Day 42	0 0%	0 0%	0 0%	0 0%
AST (U/L)-Day 98	0 0%	0 0%	0 0%	0 0%
AST (U/L)-Day 175	0 0%	0 0%	0 0%	0 0%
AST (U/L)-Day 182	0 0%	0 0%	0 0%	0 0%
AST (U/L)-Day 273	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Screening	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)-Day 14	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)-Day 42	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)-Day 98	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)-Day 175	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)-Day 182	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)-Day 273	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Screening	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)-Day 14	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)-Day 42	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)-Day 98	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)-Day 175	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)-Day 182	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)-Day 273	0 0%	1 4%	0 0%	0 0%
creatine phosphokinase (U/L)- Screening	0 0%	0 0%	0 0%	0 0%
creatine phosphokinase (U/L)-Day 14	0 0%	0 0%	0 0%	0 0%
creatine phosphokinase (U/L)-Day 42	0 0%	0 0%	0 0%	1 33.3%
creatine phosphokinase (U/L)-Day 98	0 0%	0 0%	0 0%	0 0%
creatine phosphokinase (U/L)-Day 175	0 0%	0 0%	0 0%	0 0%
creatine phosphokinase (U/L)-Day 182	0 0%	0 0%	0 0%	0 0%
creatine phosphokinase (U/L)-Day 273	0 0%	2 8%	0 0%	0 0%

10. Primary Outcome

Title	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Description	The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Time Frame	Measured through Month 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
Refused study product administration	3 12%	1 4%	0 0%	1 33.3%
Clinical event (not reacto, HIV, death)	1 4%	1 4%	0 0%	0 0%
Investigator decision	1 4%	0 0%	0 0%	0 0%
EP device difficulty	0 0%	1 4%	0 0%	0 0%
Participant Relocated	0 0%	1 4%	0 0%	0 0%
Did not discontinue SPA	20 80%	21 84%	3 100%	2 66.7%

11. Primary Outcome

Title	Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
Description	A visual analog scale is a horizontal line, 10 cm in length, anchored by word descriptors at each end ("no pain" and "worst pain"). The visual analog scale score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks, 0 cm being no pain and 10 cm being maximum pain.The pain assessment scores for each arm at each vaccination visit were summarized with visual analog scale (VAS)
Time Frame	Measured during Day 0, 28, 84 and 168

Outcome Measure Data

Analysis Population Description

One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment visit. One participant in Group 2 experienced EP device difficulty on enrollment visit. These two participants had no Visual Analog Scale - Pain Assessment Scores.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
0 - V2.0 - Day 0	4.65	4.75	6.9	4.9
5-7 - V2.0 - Day 0	0.8	0.85	2.2	1.7
25_60 - V2.0 - Day 0	0.45	0.7	1.7	0.7
0 - V4.0 - Day 28	4.3	3.65	5.5	3.3
5-7 - V4.0 - Day 28	1.6	0.7	2.4	1.05
25_60 - V4.0 - Day 28	0.5	0.5	1.8	0.65
0 - V7.0 - Day 84	3.95	3.6	6.85	5
5-7 - V7.0 - Day 84	1.1	0.8	1.7	2.15
25_60 - V7.0 - Day 84	0.55	0.3	1.1	1.9
0 - V9.0 - Day 168	5.1	3.95	3.4	2.6
5-7 - V9.0 - Day 168	0.8	0.6	2.4	0.75
25_60 - V9.0 - Day 168	0.2	0.3	0.8	0.3

12. Primary Outcome

Title	Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Description	Distribution of responses to questions regarding acceptability of study injection procedures [ Visits 3, 5, 8, 10] were summarized by category (Acceptable/Unacceptable/Don?t know/ Don?t Remember)
Time Frame	Measured during Visit 3 (Day14), Visit 5 (Day 35), Visit 8 (Day 98), Visit 10 (Day 175)

Outcome Measure Data

Analysis Population Description

One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment. One participant in Group 2 had an interim visit done as the visit was done prior to the visit 3.0 window opening. Data Manager instructed site to complete the interim visit and then following w/ a missed visit. These two cases were missed in the enrollment visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Control 1	Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines	P55gag (gag/gag) vaccines	Placebo: Sodium Chloride, USP 0.9%	Placebo: Sodium Chloride, USP 0.9%
Measure Participants	25	25	3	3
Question-1- Acceptable- Day 14	17 68%	20 80%	3 100%	2 66.7%
Question-1- Unacceptable- Day 14	7 28%	2 8%	0 0%	1 33.3%
Question-1- Don't Know/Don't Remember- Day 14	0 0%	2 8%	0 0%	0 0%
Question-1- Acceptable- Day 175	16 64%	19 76%	3 100%	2 66.7%
Question-1- Unacceptable- Day 175	2 8%	2 8%	0 0%	0 0%
Question-1- Don't Know/Don't Remember- Day 175	0 0%	0 0%	0 0%	0 0%
Question-1- Acceptable- Day 35	20 80%	20 80%	3 100%	2 66.7%
Question-1- Unacceptable- Day 35	3 12%	2 8%	0 0%	0 0%
Question-1- Don't Know/Don't Remember- Day 35	0 0%	0 0%	0 0%	0 0%
Question-1- Acceptable- Day 98	19 76%	18 72%	3 100%	2 66.7%
Question-1- Unacceptable- Day 98	3 12%	3 12%	0 0%	0 0%
Question-1- Don't Know/Don't Remember- Day 98	0 0%	1 4%	0 0%	0 0%
Question-2- Acceptable- Day 14	22 88%	23 92%	3 100%	3 100%
Question-2- Unacceptable- Day 14	2 8%	0 0%	0 0%	0 0%
Question-2- Don't Know/Don't Remember- Day 14	0 0%	1 4%	0 0%	0 0%
Question-2- Acceptable- Day 175	17 68%	21 84%	3 100%	2 66.7%
Question-2- Unacceptable- Day 175	1 4%	0 0%	0 0%	0 0%
Question-2- Don't Know/Don't Remember- Day 175	0 0%	0 0%	0 0%	0 0%
Question-2- Acceptable- Day 35	22 88%	20 80%	3 100%	2 66.7%
Question-2- Unacceptable- Day 35	1 4%	2 8%	0 0%	0 0%
Question-2- Don't Know/Don't Remember- Day 35	0 0%	0 0%	0 0%	0 0%
Question-2- Acceptable- Day 98	20 80%	21 84%	3 100%	2 66.7%
Question-2- Unacceptable- Day 98	2 8%	0 0%	0 0%	0 0%
Question-2- Don't Know/Don't Remember- Day 98	0 0%	1 4%	0 0%	0 0%
Question-3- Acceptable- Day 14	19 76%	21 84%	2 66.7%	3 100%
Question-3- Unacceptable- Day 14	4 16%	2 8%	1 33.3%	0 0%
Question-3- Don't Know/Don't Remember- Day 14	1 4%	1 4%	0 0%	0 0%
Question-3- Acceptable- Day 175	15 60%	18 72%	1 33.3%	2 66.7%
Question-3- Unacceptable- Day 175	3 12%	3 12%	0 0%	0 0%
Question-3- Don't Know/Don't Remember- Day 175	0 0%	0 0%	2 66.7%	0 0%
Question-3- Acceptable- Day 35	18 72%	19 76%	3 100%	2 66.7%
Question-3- Unacceptable- Day 35	5 20%	3 12%	0 0%	0 0%
Question-3- Don't Know/Don't Remember- Day 35	0 0%	0 0%	0 0%	0 0%
Question-3- Acceptable- Day 98	20 80%	19 76%	2 66.7%	2 66.7%
Question-3- Unacceptable- Day 98	2 8%	3 12%	1 33.3%	0 0%
Question-3- Don't Know/Don't Remember- Day 98	0 0%	0 0%	0 0%	0 0%
Question-4- Acceptable- Day 14	24 96%	24 96%	3 100%	3 100%
Question-4- Unacceptable- Day 14	0 0%	0 0%	0 0%	0 0%
Question-4- Don't Know/Don't Remember- Day 14	0 0%	0 0%	0 0%	0 0%
Question-4- Acceptable- Day 175	18 72%	20 80%	3 100%	2 66.7%
Question-4- Unacceptable- Day 175	0 0%	1 4%	0 0%	0 0%
Question-4- Don't Know/Don't Remember- Day 175	0 0%	0 0%	0 0%	0 0%
Question-4- Acceptable- Day 35	23 92%	20 80%	2 66.7%	2 66.7%
Question-4- Unacceptable- Day 35	0 0%	2 8%	1 33.3%	0 0%
Question-4- Don't Know/Don't Remember- Day 35	0 0%	0 0%	0 0%	0 0%
Question-4- Acceptable- Day 98	22 88%	21 84%	3 100%	2 66.7%
Question-4- Unacceptable- Day 98	0 0%	0 0%	0 0%	0 0%
Question-4- Don't Know/Don't Remember- Day 98	0 0%	1 4%	0 0%	0 0%
Question-5- Acceptable- Day 14	4 16%	8 32%	0 0%	0 0%
Question-5- Unacceptable- Day 14	0 0%	0 0%	0 0%	0 0%
Question-5- Don't Know/Don't Remember- Day 14	0 0%	1 4%	1 33.3%	0 0%
Question-5- No Other Side Effects- Day 14	20 80%	15 60%	2 66.7%	3 100%
Question-5- Acceptable- Day 175	2 8%	1 4%	0 0%	1 33.3%
Question-5- Unacceptable- Day 175	1 4%	0 0%	0 0%	0 0%
Question-5- Don't Know/Don't Remember- Day 175	0 0%	0 0%	0 0%	0 0%
Question-5- No Other Side Effects- Day 175	15 60%	20 80%	3 100%	1 33.3%
Question-5- Acceptable- Day 35	4 16%	5 20%	1 33.3%	0 0%
Question-5- Unacceptable- Day 35	0 0%	2 8%	0 0%	0 0%
Question-5- Don't Know/Don't Remember- Day 35	0 0%	0 0%	0 0%	0 0%
Question-5- No Other Side Effects- Day 35	19 76%	15 60%	2 66.7%	2 66.7%
Question-5- Acceptable- Day 98	1 4%	4 16%	0 0%	0 0%
Question-5- Unacceptable- Day 98	0 0%	1 4%	0 0%	0 0%
Question-5- Don't Know/Don't Remember- Day 98	1 4%	1 4%	0 0%	0 0%
Question-5- No Other Side Effects- Day 98	20 80%	16 64%	3 100%	2 66.7%

Adverse Events

Time Frame	Measured through Month 12
Adverse Event Reporting Description	Number of Participants Reporting Adverse Events (AEs)
Arm/Group Title	Group 1: Vaccine		Group 2: Vaccine		Group 3: Control 1		Group 4: Control 2
Arm/Group Description	P24CE1/2(CE/CE) + gag vaccines		P55gag (gag/gag) vaccines		Placebo: Sodium Chloride, USP 0.9%		Placebo: Sodium Chloride, USP 0.9%
All Cause Mortality
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Control 1		Group 4: Control 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/3 (0%)		0/3 (0%)
Serious Adverse Events
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Control 1		Group 4: Control 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Control 1		Group 4: Control 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/25 (64%)		17/25 (68%)		2/3 (66.7%)		2/3 (66.7%)
Blood and lymphatic system disorders
Any Event in SOC	1/25 (4%)	1	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Lymphadenopathy	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Neutropenia	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Gastrointestinal disorders
Any Event in SOC	2/25 (8%)	2	1/25 (4%)	3	1/3 (33.3%)	1	0/3 (0%)	0
Diarrhoea	1/25 (4%)	1	1/25 (4%)	2	0/3 (0%)	0	0/3 (0%)	0
Dyspepsia	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Haemorrhoidal haemorrhage	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Toothache	0/25 (0%)	0	0/25 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0
General disorders
Any Event in SOC	2/25 (8%)	3	2/25 (8%)	2	1/3 (33.3%)	1	1/3 (33.3%)	1
Chest pain	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Complication of device removal	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Influenza like illness	1/25 (4%)	2	1/25 (4%)	1	0/3 (0%)	0	1/3 (33.3%)	1
Pain	0/25 (0%)	0	0/25 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0
Infections and infestations
Any Event in SOC	6/25 (24%)	9	8/25 (32%)	11	1/3 (33.3%)	1	1/3 (33.3%)	3
Bronchitis	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Gastroenteritis	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Gingivitis	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Influenza	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Nasopharyngitis	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Tinea pedis	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Upper respiratory tract infection	5/25 (20%)	7	4/25 (16%)	6	0/3 (0%)	0	1/3 (33.3%)	1
Urinary tract infection	0/25 (0%)	0	0/25 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1
Viral infection	0/25 (0%)	0	0/25 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0
Viral upper respiratory tract infection	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Vulvovaginal candidiasis	0/25 (0%)	0	0/25 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1
Injury, poisoning and procedural complications
Any Event in SOC	2/25 (8%)	4	3/25 (12%)	4	0/3 (0%)	0	2/3 (66.7%)	2
Animal bite	0/25 (0%)	0	0/25 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1
Arthropod bite	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Concussion	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Limb injury	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Procedural dizziness	2/25 (8%)	3	0/25 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1
Skin abrasion	1/25 (4%)	1	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Investigations
Any Event in SOC	4/25 (16%)	8	5/25 (20%)	6	0/3 (0%)	0	1/3 (33.3%)	3
Alanine aminotransferase increased	1/25 (4%)	3	0/25 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1
Aspartate aminotransferase increased	1/25 (4%)	1	1/25 (4%)	1	0/3 (0%)	0	1/3 (33.3%)	1
Blood creatine phosphokinase increased	2/25 (8%)	2	3/25 (12%)	3	0/3 (0%)	0	1/3 (33.3%)	1
Blood pressure increased	1/25 (4%)	1	2/25 (8%)	2	0/3 (0%)	0	0/3 (0%)	0
Haemoglobin decreased	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Musculoskeletal and connective tissue disorders
Any Event in SOC	4/25 (16%)	6	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Arthralgia	1/25 (4%)	1	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Back pain	2/25 (8%)	2	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Muscle spasms	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Musculoskeletal chest pain	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Pain in extremity	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Oral papilloma	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Nervous system disorders
Any Event in SOC	4/25 (16%)	6	2/25 (8%)	2	1/3 (33.3%)	1	0/3 (0%)	0
Carpal tunnel syndrome	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Dizziness	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Headache	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Presyncope	2/25 (8%)	2	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Psychomotor hyperactivity	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Seizure	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Syncope	1/25 (4%)	1	0/25 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0
Psychiatric disorders
Any Event in SOC	3/25 (12%)	5	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Anxiety	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Depression	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Insomnia	2/25 (8%)	4	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Renal and urinary disorders
Any Event in SOC	2/25 (8%)	3	3/25 (12%)	4	0/3 (0%)	0	0/3 (0%)	0
Haematuria	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Proteinuria	2/25 (8%)	3	3/25 (12%)	3	0/3 (0%)	0	0/3 (0%)	0
Reproductive system and breast disorders
Any Event in SOC	1/25 (4%)	1	1/25 (4%)	1	0/3 (0%)	0	1/3 (33.3%)	1
Cervical dysplasia	0/25 (0%)	0	0/25 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1
Premenstrual dysphoric disorder	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Vaginal discharge	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
Any Event in SOC	0/25 (0%)	0	3/25 (12%)	3	0/3 (0%)	0	0/3 (0%)	0
Cough	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Oropharyngeal pain	0/25 (0%)	0	2/25 (8%)	2	0/3 (0%)	0	0/3 (0%)	0
Skin and subcutaneous tissue disorders
Any Event in SOC	1/25 (4%)	1	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Dermatitis contact	0/25 (0%)	0	1/25 (4%)	1	0/3 (0%)	0	0/3 (0%)	0
Erythema	1/25 (4%)	1	0/25 (0%)	0	0/3 (0%)	0	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.