Evaluating the Safety and Immunogenicity of an HIV Vaccin... | NCT03382418

ID	Type	Description	Link
12030	Registry Identifier	DAIDS-ES Registry Number

Label	Type	Description	Intervention Names
Group 1: gp145 C.6980 (high dose)	Experimental	Participants will receive 300 mcg of the gp145 C.6980 vaccine admixed with aluminum hydroxide adjuvant at Day 0 and Months 2 and 6.	Biological: gp145 C.6980 Vaccine Biological: Aluminum Hydroxide Adjuvant
Group 2: gp145 C.6980 (low dose)	Experimental	Participants will receive 100 mcg of the gp145 C.6980 vaccine admixed with aluminum hydroxide adjuvant at Day 0 and Months 2 and 6.	Biological: gp145 C.6980 Vaccine Biological: Aluminum Hydroxide Adjuvant
Group 3: Placebo	Placebo Comparator	Participants will receive placebo at Day 0 and Months 2 and 6.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
gp145 C.6980 Vaccine	Biological	Administered by intramuscular injection in the deltoid.	Group 1: gp145 C.6980 (high dose) Group 2: gp145 C.6980 (low dose)

Measure	Description	Time Frame
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.	Measured through 7 days after first vaccination at Month 0
Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration	Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.	Measured through 7 days after first vaccination at Month 0
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.	Measured through 7 days after first vaccination at Month 0
Number of Participants Reporting Adverse Events (AEs), by Severity Grade	Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.	Measured through 30 days after first vaccination at Month 0

Measure	Description	Time Frame
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.	Measured through Month 6.5

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 and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items initially answered incorrectly
Agrees not to enroll in another study of an investigational research agent before the last scheduled protocol clinic visit
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. Low risk guidelines are found on the protocol web page under Study Materials on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn122).

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 to 550,000/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 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 122 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 122 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 122 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 122 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 122 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 122 PSRT on a case-by-case basis.
Live attenuated vaccines other than influenza vaccine received within 30 days before or scheduled and intended to be received within 14 days after the first vaccination (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
Influenza vaccine or 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 and intended to be received 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 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
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 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 3 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
Katharine Bar	University of Pennsylvania	Study Chair
Hong Van Tieu	New York Blood Center	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Columbia P&S CRS		New York	New York	10032-3732	United States
New York Blood Center CRS

PubMed Identifier	Type	Citation	Retractions
37679276	Derived	Tieu HV, Karuna S, Huang Y, Sobieszczyk ME, Zheng H, Tomaras GD, Montefiori DC, Shen M, DeRosa S, Cohen K, Isaacs MB, Regenold S, Heptinstall J, Seaton KE, Sawant S, Furch B, Pensiero M, Corey L, Bar KJ; HVTN 122 Study Team. Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1-uninfected adult participants in the US. Vaccine. 2023 Oct 6;41(42):6309-6317. doi: 10.1016/j.vaccine.2023.07.046. Epub 2023 Sep 9.

ID	Title	Description
FG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
FG001	Group 2: Vaccine

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 27, 2017	Nov 16, 2020

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: Pain and/or Tenderness

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.

Posted

Count of Participants

Participants

Measured through 7 days after first vaccination at Month 0

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts
Participants	OG00025 OG00115 OG0025

Title

Denominators

Categories

Title	Measurements
Pain and/or Tenderness None	OG0009 OG0014 OG0024
Mild

Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration

Posted

Count of Participants

Participants

Measured through 7 days after first vaccination at Month 0

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts

Primary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.

Posted

Count of Participants

Participants

Measured through 7 days after first vaccination at Month 0

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Primary

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

Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); 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 first vaccination at Month 0

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts

Primary

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

Posted

Count of Participants

Participants

Measured through 30 days after first vaccination at Month 0

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts

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 30 days after first vaccination at Month 0

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts
Participants

Primary

Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination

Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with grade 1 or higher results are 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 at 2 weeks after first vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Primary

Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets

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

Posted

Median

Inter-Quartile Range

thousand cells/cubic mm

Measured at 2 weeks after first vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Primary

Chemistry Laboratory Measures: Hemoglobin, Creatinine

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

Posted

Median

Inter-Quartile Range

g/dL

Measured at 2 weeks after first vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Primary

Chemistry Laboratory Measures: ALT

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

Posted

Median

Inter-Quartile Range

U/L

Measured at 2 weeks after first vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Secondary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Posted

Count of Participants

Participants

Measured through Month 6.5

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts
Participants

Secondary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration

Posted

Count of Participants

Participants

Measured through Month 6.5

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts
Participants

Secondary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Posted

Count of Participants

Participants

Measured through Month 6.5

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Secondary

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

Posted

Count of Participants

Participants

Measured through Month 7

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts

Secondary

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

Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); for participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

Posted

Count of Participants

Participants

Measured through Month 7

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts

Secondary

Frequency of 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 12

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Units	Counts
Participants

Secondary

Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations

Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.

Posted

Count of Participants

Participants

Measured during Screening, Month 0.5, 2.5, 6.5 and 9

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Secondary

Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations

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

Posted

Median

Inter-Quartile Range

thousand cells/cubic mm

Measured during Screening, Month 0.5, 2.5, 6.5 and 9

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Secondary

Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations

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

Posted

Median

Inter-Quartile Range

g/dL

Measured during Screening, Month 0.5, 2.5, 6.5 and 9

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Secondary

Chemistry Laboratory Measures: ALT, Through All Vaccinations

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

Posted

Median

Inter-Quartile Range

U/L

Measured during Screening, Month 0.5, 2.5, 6.5 and 9

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6

Secondary

Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)

Serum HIV-1-specific 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

"Overall Number of Participants Analyzed" includes those with samples collected at week 2, who were HIV-uninfected and received the first vaccination. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.

Posted

Count of Participants

Participants

Measured at 2 weeks after the first vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6

Secondary

Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)

Posted

Median

Inter-Quartile Range

mean fluorescent intensity (MFI)

Measured at 2 weeks after the first vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6

Secondary

Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)

"Overall Number of Participants Analyzed" includes those with samples collected at month 6.5, who were HIV-uninfected. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.

Posted

Count of Participants

Participants

Measured at 2 weeks after the third vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001

Secondary

Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)

Posted

Median

Inter-Quartile Range

mean fluorescent intensity (MFI)

Measured at 2 weeks after the third vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6

Secondary

Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. 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 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 p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

"Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.

Posted

Count of Participants

Participants

Measured at 2 weeks after the third vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine

Secondary

Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry.

"Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.

Posted

Median

Inter-Quartile Range

% of T-cell

Measured at 2 weeks after the third vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine

Secondary

Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates

Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells.

Posted

Count of Participants

Participants

Measured at 2 weeks after the third vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6

Secondary

Level of Neutralizing Antibody Responses Against HIV-1 Isolates

Posted

Median

Full Range

Titer

Measured at 2 weeks after the third vaccination

ID	Title	Description
OG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
OG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Any SOC	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0008 events6 affected25 at risk EG0011 events1 affected15 at risk EG0021 events1 affected5 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected15 at risk EG0021 events1 affected5 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	General disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0021 events1 affected5 at risk
Influenza like illness	General disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected15 at risk EG0021 events1 affected5 at risk
Injection site pruritus	General disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0009 events7 affected25 at risk EG0017 events4 affected15 at risk EG0022 events2 affected5 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Body tinea	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Cystitis	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Papilloma viral infection	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Respiratory tract infection	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Sinusitis	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Viral infection	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0021 events1 affected5 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0021 events1 affected5 at risk
Any SOC	Injury, poisoning and procedural complications	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected15 at risk EG0021 events1 affected5 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected15 at risk EG0021 events1 affected5 at risk
Any SOC	Investigations	MedDRA 22.1	Non-systematic Assessment	EG0006 events5 affected25 at risk EG0016 events3 affected15 at risk EG0020 events0 affected5 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected15 at risk EG0020 events0 affected5 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.1	Non-systematic Assessment	EG0002 events2 affected25 at risk EG0012 events2 affected15 at risk EG0020 events0 affected5 at risk
Blood creatinine increased	Investigations	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Blood pressure increased	Investigations	MedDRA 22.1	Non-systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Neutrophil count decreased	Investigations	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
White blood cell count decreased	Investigations	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Metabolism and nutrition disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Nervous system disorders	MedDRA 22.1	Non-systematic Assessment	EG0002 events1 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Dysarthria	Nervous system disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Paraesthesia	Nervous system disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Renal and urinary disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0022 events1 affected5 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected15 at risk EG0021 events1 affected5 at risk
Proteinuria	Renal and urinary disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected15 at risk EG0021 events1 affected5 at risk
Renal failure	Renal and urinary disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Reproductive system and breast disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 22.1	Non-systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Any SOC	Skin and subcutaneous tissue disorders	MedDRA 22.1	Non-systematic Assessment	EG0004 events3 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 22.1	Non-systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected15 at risk EG0020 events0 affected5 at risk

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	Title	Description
BG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
BG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6
BG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1: Vaccine	gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6	25	1	25	15	25
EG001	Group 2: Vaccine	gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6	15	0	15	8	15
EG002	Group 3: Placebo	Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6	5	0	5	4	5