Evaluating the Safety and Immunogenicity of Env (A,B,C,A/... | NCT03409276

ID	Type	Description	Link
38302	Registry Identifier	DAIDS-ES Registry Number

Label	Type	Description	Intervention Names
Group 1 (Treatment): Protein Vaccine/GLA-SE	Experimental	Participants will receive 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant at Day 0 and Month 2.	Biological: gp120 (A,B,C,A/E) Protein Vaccine Biological: GLA-SE adjuvant
Group 1 (Control)	Placebo Comparator	Participants will receive placebo at Day 0 and Month 2.	Biological: Placebo
Group 2 (Treatment) DNA Vaccine+Placebo+Protein Vaccine/GLA-SE	Experimental	Participants will receive 2 mg of env (A,B,C,A/E)/gag (C) DNA vaccine and placebo at Day 0 and Months 1 and 3. Participants will receive 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant and a placebo vaccine at Months 6 and 8.	Biological: env (A,B,C,A/E)/gag (C) DNA Vaccine Biological: gp120 (A,B,C,A/E) Protein Vaccine Biological: Placebo Biological: GLA-SE adjuvant
Group 2 (Control)	Placebo Comparator	Participants will receive placebo at Day 0 and Months 1, 3, 6, and 8.	Biological: Placebo
Group 3 (Treatment): DNA Vaccine+Protein Vaccine/GLA-SE	Experimental

Name	Type	Description	Arm Group Labels	Other Names
env (A,B,C,A/E)/gag (C) DNA Vaccine	Biological	Administered by intramuscular injection in the deltoid.	Group 2 (Treatment) DNA Vaccine+Placebo+Protein Vaccine/GLA-SE

Measure	Description	Time Frame
Number of Participants Reporting Local Reactogenicity Signs and Symptoms	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 over the time frame is presented.	Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	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 over the time frame is presented.	Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product	For participants reporting multiple AEs over the time frame, the maximum relationship is counted.	Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Adverse Events (AEs), by Severity Grade	For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.	Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Serious Adverse Events (SAEs)	Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).	Measured through Month 8 for part A and Month 14 for part B

Measure	Description	Time Frame
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination	Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1, and net MFI > 22,000 is set to 22,000. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500.

Eligibility Module

Eligibility Criteria

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
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Willing to be contacted 12 months after the last vaccination
Agrees not to enroll in another study of an investigational research agent
Good general health as shown by medical history, physical exam, and screening laboratory tests

HIV-Related Criteria:

Willingness to receive HIV test results
Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
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

Hemogram/Complete Blood Count (CBC)

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/mm^3 to 450,000/mm^3

Chemistry

Chemistry panel: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 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: US volunteers must have a negative US 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

Urine

Normal urine:
- Negative urine glucose, and
- Negative or trace urine protein, and
- Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).

Reproductive Status

Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must:
- Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until after the last required protocol clinic visit. Effective contraception is defined as using the following methods:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- Any other contraceptive method approved by the HVTN 124 Protocol Safety Review Team (PSRT)
- Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
- 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.
Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

Exclusion Criteria:

General

Blood products received within 120 days before first vaccination
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 HVTN 124 study
Pregnant or breastfeeding
Active duty and reserve US 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 124 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. Exceptions may be made by the HVTN 124 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 124 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 124 PSRT on a case-by-case basis.
Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination

Immune System

Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than 60 mg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)
Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination
Autoimmune disease, connective tissue disease, or history of vasculitis, e.g., leukocytoclastic vasculitis, Henoch-Schonlein purpura
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. A clinically significant condition or process includes but is not limited to:
- A process that would affect the immune response,
- A process that would require medication that affects the immune response,
- Any contraindication to repeated injections or blood draws,
- A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
- A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
- Any condition specifically listed among the exclusion criteria below.
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. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:
- Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- Uses moderate/high dose inhaled corticosteroids, or
- In the past year has either of the following:
- Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
- Needed emergency care, urgent care, hospitalization, or intubation for 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:
- If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
- If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Asplenia: any condition resulting in the absence of a functional spleen
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.

Name	Affiliation	Role
Ian Frank	University of Pennsylvania	Study Chair
Turner Overton	University of Alabama at Birmingham	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Alabama CRS		Birmingham	Alabama	35294	United States
The Hope Clinic of the Emory Vaccine Center CRS

PubMed Identifier	Type	Citation	Retractions
41212034	Derived	Jamieson PJ, Shen X, Abu-Shmais AA, Wasdin PT, Janowska K, Edwards RJ, Scapellato G, Bukenya M, Bass LE, Richardson SI, Manamela NP, Liu S, Barr M, Adams L, Paola Velez-Castro C, McCarthy C, Alexander CA, Gillespie RA, Mimms J, Suryadevara N, Sornberger TA, Zost SJ, Parks R, Flaherty S, Janke AK, Howard BN, Suresh YP, Ruprecht RM, Crowe JE Jr, Carnahan RH, Bailey JR, Kanekiyo M, Lingwood D, Haynes BF, Moore PL, Bonami RH, Tomaras GD, Archarya P, Montefiori DC, Kalams SA, Lu S, Georgiev IS. Glycan-reactive antibodies isolated from human HIV-1 vaccine trial participants show broad pathogen cross-reactivity. J Virol. 2025 Dec 23;99(12):e0125625. doi: 10.1128/jvi.01256-25. Epub 2025 Nov 10.
40190112

ID	Title	Description
FG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
FG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 28, 2017	Oct 14, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms

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 over the time frame is presented.

Posted

Count of Participants

Participants

Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
OG004	Part B: Vaccine 2	DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)

Units	Counts
Participants	OG0002 OG00110 OG0026 OG003

Title

Denominators

Categories

Pain

Title	Measurements
None	OG0002 OG0015 OG0025 OG003

Primary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Posted

Count of Participants

Participants

Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
OG004	Part B: Vaccine 2

Primary

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

For participants reporting multiple AEs over the time frame, the maximum relationship is counted.

Posted

Count of Participants

Participants

Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
OG004	Part B: Vaccine 2	DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)

Primary

Number of Participants Reporting Adverse Events (AEs), by Severity Grade

For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

Posted

Count of Participants

Participants

Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
OG004	Part B: Vaccine 2	DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)

Primary

Number of Participants Reporting Serious Adverse Events (SAEs)

Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).

Posted

Count of Participants

Participants

Measured through Month 8 for part A and Month 14 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
OG004	Part B: Vaccine 2	DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)

Primary

Number of Participants Reporting Adverse Events of Special Interest (AESIs)

Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases. There were no adverse events of special interest reported by any participant.

Posted

Count of Participants

Participants

Measured through Month 8 for part A and Month 14 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
OG004	Part B: Vaccine 2

Primary

Numbers of Participants With Grade 1 or Higher Local Laboratory Results

The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point. Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.

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.

Posted

Count of Participants

Participants

Measured during Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)

Primary

Alk Phos, AST, ALT in UL

Laboratory results are summarized by analyte and timepoint.

Posted

Median

Inter-Quartile Range

U/L

Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)

Primary

Hemoglobin, Creatinine in g/dL

Laboratory results are summarized by analyte and timepoint.

Posted

Median

Inter-Quartile Range

g/dL

Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)

Primary

WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm

Laboratory results are summarized by analyte and timepoint.

Posted

Median

Inter-Quartile Range

thousand cells/cubic mm

Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1

Primary

Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation

From the study product discontinuation form, study product administration reasons are tabulated by treatment arm

Posted

Count of Participants

Participants

Measured through study completion, up to 31 months

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
OG004	Part B: Vaccine 2	DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)

Secondary

Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination

Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1, and net MFI > 22,000 is set to 22,000. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500.

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria (excluding the reference antigen record which exceeds 5000 MFI etc.).

Posted

Count of Participants

Participants

Measured at Month 2.5 for part A and 8.5 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)

Secondary

Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination

Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 12).

Posted

Median

Inter-Quartile Range

relative fluorescence units

Measured at Month 2.5 for part A and 8.5 for part B

ID	Title	Description
OG000	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
OG001	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)

Secondary

Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination

Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. Magnitude-breadth (MB) curves characterized the magnitude (Binding antibody MFI* at 1:50 dilution and titer) and breadth (number of antigens with positive response at given MFI* or titer) of each individual plasma sample assayed against a panel of antigens. The x-axis represents the response magnitude and the y-axis represents the fraction of antigens with response magnitude greater than the x-axis value. In addition to the individual sample specific curves, the group-specific curve displayed the average MB across all participants in that group. The area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI* (log10 titer) over the panel of antigens.

Posted

Median

Inter-Quartile Range

log10 titer* proportion of antigens

Measured at Month 2.5 for part A and 8.5 for part B

ID	Title	Description
OG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
OG001	Part A: Vaccine

Secondary

Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination

Neutralizing antibodies against HIV1were measured as a function of reductions in Tat-regulatedluciferase (Luc) reporter gene expression in TZM-blcells. The assay performed in TZM-bl cells measured neutralization titers against a panel of Env-pseudotyped viruses that exhibit the following naturalization phenotypes. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (ID50 and ID80, cells only). The prespecified cutoff was 20 for MW965.26 (Tier 1a) and 10 for other viruses.

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available Neutralizing Antibody data after filtering for assay specific quality control criteria.

Posted

Count of Participants

Participants

Measured at Month 8.5 for part B only

ID	Title	Description
OG000	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG001	Part B: Vaccine 1

Secondary

Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available Neutralizing Antibody data after filtering for assay specific quality control criteria.

Posted

Median

Inter-Quartile Range

Titers

Measured at Month 8.5 for part B only

ID	Title	Description
OG000	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
OG001	Part B: Vaccine 1

Secondary

Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B

For Binding Antibody Multiplex Assay, gp70-V1V2 IgG, the area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI* (log10 titer) over the panel of antigens. For ADCC GranToxiLux, AUC-MB was calculated as the average of the AUC over the panel of antigens, where AUC is defined as nonparametric area under the net percent granzyme B activity vs log10 (dilution) curve ("AUC"), calculated using the trapezoidal rule, and setting any net percent granzyme B activity below 0% to 0%. For ADCC Luciferase, (AUC-MB) was calculated as the average of the pAUC over the panel of antigens, where pAUC is defined as nonparametric partial area under the baseline subtracted curves ("pAUC"), calculated using the trapezoidal rule on the first four dilutions of the baseline subtracted curves, setting baseline subtracted loss Luciferase activity less than 0% to zero.

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA, or ADCC data after filtering for assay specific quality control criteria. Assay data were not collected for gp120 IgA per lab study plan.

Posted

Median

Inter-Quartile Range

log10 titer* proportion of antigens

Measured at Month 8.5 for part B only

ID	Title	Description
OG000	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)

Secondary

Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value <=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

Posted

Count of Participants

Participants

Measured at Month 8.5 for part B only

ID	Title	Description
OG000	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)

Secondary

Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

Posted

Median

Inter-Quartile Range

% CD4+ T-cells

Measured at Month 8.5 for part B only

ID	Title	Description
OG000	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)

Secondary

Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

Posted

Count of Participants

Participants

Measured at Month 8.5 for part B only

ID	Title	Description
OG000	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)

Secondary

Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.

In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

Posted

Median

Inter-Quartile Range

% CD8+ T-cells

Measured at Month 8.5 for part B only

ID	Title	Description
OG000	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Any Event in SOC	Blood and lymphatic system disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG0033 events2 affected21 at risk EG0040 events0 affected21 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Ear and labyrinth disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Eustachian tube dysfunction	Ear and labyrinth disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0024 events4 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Anal fissure	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Anal fissure haemorrhage	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Cannabinoid hyperemesis syndrome	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0022 events2 affected6 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Haematemesis	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Tongue ulceration	Gastrointestinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	General disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Chest pain	General disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Cyst	General disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Influenza like illness	General disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Injection site pruritus	General disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Hepatobiliary disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0013 events3 affected10 at risk EG0024 events3 affected6 at risk EG003
Abscess limb	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Body tinea	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Bronchitis viral	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Cellulitis	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Febrile infection	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Gastroenteritis viral	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Influenza	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Otitis media	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Pneumonia	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Respiratory tract infection viral	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Sinusitis	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Tooth abscess	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Upper respiratory tract infection	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0012 events2 affected10 at risk EG0022 events1 affected6 at risk EG003
Urinary tract infection	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Viral infection	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Injury, poisoning and procedural complications	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk EG003
Nasal injury	Injury, poisoning and procedural complications	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Post procedural swelling	Injury, poisoning and procedural complications	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Investigations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0014 events3 affected10 at risk EG0021 events1 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Blood creatinine increased	Investigations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0012 events2 affected10 at risk EG0021 events1 affected6 at risk EG003
Blood glucose increased	Investigations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Blood pressure increased	Investigations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Red blood cells urine positive	Investigations	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Nervous system disorders	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Headache	Nervous system disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Migraine	Nervous system disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Syncope	Nervous system disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Tardive dyskinesia	Nervous system disorders	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Psychiatric disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk EG003
Anxiety	Psychiatric disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Depression	Psychiatric disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Insomnia	Psychiatric disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Nightmare	Psychiatric disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Panic attack	Psychiatric disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Renal and urinary disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0022 events1 affected6 at risk EG003
Glycosuria	Renal and urinary disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Proteinuria	Renal and urinary disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0022 events1 affected6 at risk EG003
Any Event in SOC	Reproductive system and breast disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Breast pain	Reproductive system and breast disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Respiratory, thoracic and mediastinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Any Event in SOC	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0012 events1 affected10 at risk EG0021 events1 affected6 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Papule	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk EG003
Any Event in SOC	Vascular disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003
Flushing	Vascular disorders	MEDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk EG003

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D015752	Genes, env
D019444	Vaccines, DNA
D010957	Plasmids
D015699	HIV Envelope Protein gp120
C000608161	glucopyranosyl lipid-A

ID	Term
D005814	Genes, Viral
D064351	Genes, Microbial
D005796	Genes
D040481	Genome Components
D016678	Genome
D040342	Genetic Structures
D055614	Genetic Phenomena
D064349	Genome, Microbial
D016679	Genome, Viral
D000087504	Nucleic Acid-Based Vaccines
D014614	Vaccines, Synthetic
D011994	Recombinant Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D000941	Antigens
D001685	Biological Factors
D015488	HIV Antigens
D000956	Antigens, Viral
D014764	Viral Proteins
D054299	env Gene Products, Human Immunodeficiency Virus
D015686	Gene Products, env
D012191	Retroviridae Proteins
D054298	Human Immunodeficiency Virus Proteins
D014759	Viral Envelope Proteins
D015678	Viral Structural Proteins

ID	Title	Description
BG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
BG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)
BG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
BG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
BG004	Part B: Vaccine 2	DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
BG005	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 2)	2	2	2	2
EG001	Part A: Vaccine	Protein/ GLA-SE at Month (0, 2)	10	10	6	10
EG002	Part B: Placebo	Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)	6	6	5	6
EG003	Part B: Vaccine 1	DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)	21	21	19	21
EG004	Part B: Vaccine 2	DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)	21	21	18	21