Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants

A Phase 1 Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04212091

Enrollment

Registered

2019-12-26

Start date

2020-11-10

Completion date

2023-01-18

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or subcutaneous infusions in healthy, HIV-uninfected adult participants.

Detailed description

This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous (IV) or subcutaneous (SC) infusions in healthy, HIV-uninfected adult participants. The study will be conducted in two parts (Part A and B). Part A will include four groups (Groups 1, 2, 3, and 4) and Part B will include two groups (Groups 5 and 6). In Part A of the study, PGT121.414.LS will be administered via IV infusion at 3, 10, or 30 mg/kg (Groups 1-3) or via SC infusion at 5 mg/kg (Group 4). Participants in Part B will receive consecutive administration of PGT121.414.LS followed by VRC07-523LS, at 20 mg/kg IV each per dose (Group 5) or 5 mg/kg SC each per dose (Group 6). Participants will be followed for 32 weeks after the last study product administration via IV infusion and 24 weeks after the last study product administration via SC infusion. Participants in Groups 1, 2, and 3 will attend 8 months of study visits. Participants in Group 4 will attend 6 months of study visits. Part B participants will attend 16 months of study visits. Study visits may include physical examinations, blood and urine collection, and questionnaires.

Interventions

BIOLOGICALPGT121.414.LS

Administered via IV infusion or SC infusion, depending on the arm

BIOLOGICALVRC07-523LS

Administered via IV infusion or SC infusion, depending on the arm

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

General and Demographic Criteria * Age of 18 to 50 years * Access to a participating 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 study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent until completion of the last required 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 (see study protocol). Laboratory Inclusion Values: Hemogram/Complete Blood Count * Hemoglobin ≥11.0 g/dL for participants who were assigned female sex at birth, ≥13.0 g/dL for participants who were assigned male sex at birth. For transgender participants who have been on feminizing hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth). * White blood cell (WBC) count = 2,500 to 12,000 cells/mm\^3 * WBC differential either within institutional normal range or with site clinician approval * Platelets = 125,000 to 550,000 cells/mm\^3 Chemistry * Chemistry panel: alanine aminotransferase (ALT) \<1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). * 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 * Negative or trace urine protein Reproductive Status * Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to study product administration on the day of initial study product administration. 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 assigned female sex at birth must: * Agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. 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, * Tubal ligation, or * Any other contraceptive method approved by the HIV Vaccine Trials Network (HVTN) 136/HIV Prevention Trials Network (HPTN) 092 Protocol Safety Review Team (PSRT) * Successful vasectomy in any partner assigned male sex at birth (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 be sexually abstinent. * Volunteers who were assigned female sex at birth 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 * Weight \>115 kg * Blood products received within 120 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 136/HPTN 092 PSRT * Investigational research agents received within 30 days before first study product administration * Intent to participate in another study of an investigational research agent or any other study that requires non-Network HIV antibody testing during the planned duration of the study * Pregnant or breastfeeding 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 136/HPTN 092 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of humanized or human mAbs, whether licensed or investigational; the HVTN 136/HPTN 092 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies VRC01, VRC01LS, VRC07-523LS, or PGT121 Immune System * Immunosuppressive medications received within 30 days before first study product administration (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatological condition; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses \<20 mg/day and length of therapy \<14 days.) * Serious adverse reactions to VRC07-523LS or PGT121.414.LS formulation components (acetate, sucrose, polysorbate 80, histidine, and sorbitol; see study protocol), including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain * Immunoglobulin received within 90 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 136/HPTN 092 PSRT (for mAb see criterion above) * Autoimmune disease (Not excluded from participation: Participant with mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited AE assessments) * Immunodeficiency Clinically significant medical conditions * 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 infusions, or blood draws, including inability to establish venous or subcutaneous access, * 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 (eg, chronic urticaria or recent injection or infusion with evidence of residual inflammation) for which signs or symptoms could be confused with reactions to the study product, or * Any condition specifically listed among the

Design outcomes

Primary

Measure	Time frame	Description
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	Day 3, Months 1, 2, 4, 6, 8, 10, 12	Level of ID50 and ID80 titer data from the TZMbl neutralizing antibody assays against 1 bnAb-specific virus (CH505TF.N334S.N160A.N280D.1, sensitive to PGT121, resistant to VRC07) for all Part A participants (IV or SC administration of PGT121.414.LS alone), and 1 bnAb-specific virus (CNE55.N160K, sensitive to VRC07, resistant to PGT121) for all Part B participants (IV or SC administration of PGT121.414.LS in combination with VRC07523LS) at all expected timepoints.
Number of Participants With Early Study Termination and Reason for Early Study Termination	Measured through Month 16	The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
PGT121.414.LS and VRC07523LS Serum Concentrations	Days 0, 0.0417, 1, 2, 3, 6, 14, 28, 56, 84, 112, 112.0417, 140, 168, 196, 224, 224.0417, 252, 280, 336, 392, 448	Serum concentrations of PGT121.414.LS and VRC07-523LS at prespecified timepoints among participants who received all scheduled product administrations
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. 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 Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Measured during Screening, Days 0, 112, 168	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Measured during Screening, Days 0, 112, 168	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Measured during Screening, Days 0, 112, 168	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Measured during Screening, Days 0, 112, 168	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Measured during Screening, Days 0, 112, 168	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Number of Participants Reporting Unsolicited Adverse Events (AEs)	Measured through Month 24	The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Measured through Month 8	The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm

Secondary

Measure	Time frame	Description
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	Months 1, 4, and 9	Magnitude-breadth characterize the magnitude (ID50 or ID80 titers) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the fraction of assays with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) is calculated as the average of the log10-based ID50 or ID80 titers over the panel of isolates. Isolates includes: 0330.v4.c3, 3426.v5.c17, 377.v4.c09, AC10.0.29, Ce1176\_A3, DU156.12, DU172.17, PVO.4, RHPA4259.7, SC422661.8, T2638, andTRO.11.
Occurrence of Antidrug Antibodies (ADA)	Day 0, 112, 196, 224, 336, 392, 448	Antidrug antibodies (ADA) are most typically detected and characterized using a tiered testing strategy. In Tier I, a sensitive binding assay is used to determine if samples may have ADA present. In Tier II, the response is confirmed, typically by establishing the specificity of the response by competition with free drug. In Tier III, the response is characterized, typically with a neutralization reduction assay and/or a titering assay.

Countries

United States

Participant flow

Pre-assignment details

One participant enrolled in Group 2 was later deemed ineligible due to a preexisting autoimmune condition that required immunosuppressive treatment at the time of enrollment. The participant was included in the PK, neutralization, and ADA analysis but was excluded from the safety analysis.

Participants by arm

Arm	Count
Group 1: Vaccine PGT121.414.LS 3 mg/kg IV mo(0)	3
Group 2: Vaccine PGT121.414.LS 10 mg/kg IV mo(0)	4
Group 3: Vaccine PGT121.414.LS 30 mg/kg IV mo(0)	3
Group 4: Vaccine PGT121.414.LS 5 mg/kg SC mo(0)	3
Group 5: Vaccine PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)	10
Group 6: Vaccine PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)	10
Total	33

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Lost to Follow-up	0	0	0	0	1	1
Overall Study	Participant unable to adhere to visit	0	0	0	0	1	0

Baseline characteristics

Characteristic	Total	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine
Age, Continuous	31 years	29 years	29 years	39 years	39 years	34 years	29 years
Age, Customized 18 - 20 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized 21 - 30 years	14 Participants	2 Participants	2 Participants	1 Participants	1 Participants	3 Participants	5 Participants
Age, Customized 31 - 40 years	16 Participants	1 Participants	2 Participants	2 Participants	1 Participants	6 Participants	4 Participants
Age, Customized 41 - 50 years	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Age, Customized Above 50 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized Less than 18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants	3 Participants	4 Participants	3 Participants	3 Participants	7 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	27 Participants	2 Participants	4 Participants	3 Participants	2 Participants	9 Participants	7 Participants
Region of Enrollment USA	33 Participants	3 Participants	4 Participants	3 Participants	3 Participants	10 Participants	10 Participants
Sex: Female, Male Female	19 Participants	2 Participants	4 Participants	2 Participants	2 Participants	6 Participants	3 Participants
Sex: Female, Male Male	14 Participants	1 Participants	0 Participants	1 Participants	1 Participants	4 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 3	0 / 3	0 / 3	0 / 10	0 / 10
other Total, other adverse events	3 / 3	3 / 3	3 / 3	2 / 3	10 / 10	10 / 10
serious Total, serious adverse events	0 / 3	0 / 3	0 / 3	0 / 3	0 / 10	0 / 10

Outcome results

Primary

Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L

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

Time frame: Measured during Screening, Days 0, 112, 168

Population: '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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit. AST and Alkaline Phosphatase data were not collected at screening.

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 168	12.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 112	13.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 168	57.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 112	57.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 0/Enrollment	55.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 168	15.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 0/Enrollment	17.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Screening	14.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 112	16.0 U/L
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 0/Enrollment	18.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 0/Enrollment	13.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Screening	14.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 112	15.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 168	17.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 0/Enrollment	20.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 112	21.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 168	23.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 0/Enrollment	46.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 112	52.0 U/L
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 168	57.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 168	15.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 0/Enrollment	57.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Screening	14.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 0/Enrollment	18.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 112	14.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 0/Enrollment	15.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 112	16.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 112	55.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 168	54.0 U/L
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 168	15.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 168	15.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 0/Enrollment	63.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 0/Enrollment	14.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 168	57.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 112	60.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Screening	17.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 112	15.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 0/Enrollment	19.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 168	13.0 U/L
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 112	15.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 168	19.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 168	20.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 0/Enrollment	19.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 112	19.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Screening	13.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 0/Enrollment	61.5 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 168	73.5 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 112	68.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 112	15.0 U/L
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 0/Enrollment	15.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 112	19.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 168	58.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 0/Enrollment	15.5 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 112	18.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 0/Enrollment	17.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	AST (U/L)- Day 168	17.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Day 168	15.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 0/Enrollment	58.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	ALT (SGPT) (U/L)- Screening	16.0 U/L
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L	Alkaline Phosphatase(U/L)- Day 112	57.5 U/L

Primary

Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL

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

Time frame: Measured during Screening, Days 0, 112, 168

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Screening	1.0200 mg/dL
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 0/Enrollment	.90000 mg/dL
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 112	.91000 mg/dL
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 168	.81000 mg/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 112	.68000 mg/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 0/Enrollment	.70000 mg/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Screening	.60000 mg/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 168	.71000 mg/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 168	.90000 mg/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 112	.94000 mg/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 0/Enrollment	.94000 mg/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Screening	.97000 mg/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Screening	.73000 mg/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 168	.82000 mg/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 0/Enrollment	.75000 mg/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 112	.81000 mg/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 112	.80000 mg/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 168	.82000 mg/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 0/Enrollment	.78000 mg/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Screening	.78500 mg/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 0/Enrollment	.82000 mg/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 112	.79000 mg/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Day 168	.83000 mg/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL	Creatinine (g/dL)- Screening	.89000 mg/dL

Primary

Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL

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

Time frame: Measured during Screening, Days 0, 112, 168

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Screening	14.1 g/dL
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 0/Enrollment	13.5 g/dL
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 112	13.9 g/dL
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 168	13.5 g/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 112	12.9 g/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 0/Enrollment	12.9 g/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Screening	13.1 g/dL
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 168	13.3 g/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 168	14.0 g/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 112	14.2 g/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 0/Enrollment	13.4 g/dL
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Screening	13.8 g/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Screening	12.9 g/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 168	12.3 g/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 0/Enrollment	12.4 g/dL
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 112	12.7 g/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 112	12.6 g/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 168	12.7 g/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 0/Enrollment	12.6 g/dL
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Screening	13.6 g/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 0/Enrollment	14.2 g/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 112	14.1 g/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Day 168	14.2 g/dL
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL	Hemoglobin (g/dL)- Screening	14.1 g/dL

Primary

Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm

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

Time frame: Measured during Screening, Days 0, 112, 168

Population: 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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 112	3.80 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment	2.60 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Screening	5.05 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 168	4.51 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Screening	2.14 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment	2.26 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 112	2.20 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 168	2.10 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 168	4.37 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 168	1.99 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Screening	4.31 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 112	1.66 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment	1.55 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 112	4.20 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment	3.59 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Screening	2.06 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment	2.88 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 112	2.11 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 168	2.42 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 168	2.40 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Screening	2.10 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment	1.90 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 112	2.12 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Screening	2.83 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 112	1.99 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment	1.98 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Screening	2.00 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Screening	4.20 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 112	3.50 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 168	3.20 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 168	1.65 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment	3.70 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 168	1.68 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Screening	3.92 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Screening	2.06 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment	1.68 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 112	1.76 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment	4.01 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 112	3.65 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 168	3.71 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 168	1.86 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Screening	1.68 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 112	3.26 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 168	2.88 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment	1.89 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment	3.32 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Lymphocytes (1000 cells/cubic mm)- Day 112	1.81 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm	Neutrophils (1000 cells/cubic mm)- Screening	3.50 1000 cells/cubic mm

Primary

Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm

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

Time frame: Measured during Screening, Days 0, 112, 168

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 112	6.60 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 0/Enrollment	5.60 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Screening	7.80 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 168	6.90 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Screening	234 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 0/Enrollment	229 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 112	246 1000 cells/cubic mm
Group 1: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 168	226 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 168	7.30 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 168	313 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Screening	7.20 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 112	271 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 0/Enrollment	273 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 112	6.90 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 0/Enrollment	5.70 1000 cells/cubic mm
Group 2: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Screening	307 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 0/Enrollment	6.70 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 112	4.80 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 168	6.10 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 168	266 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Screening	252 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 0/Enrollment	244 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 112	291 1000 cells/cubic mm
Group 3: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Screening	7.70 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 112	296 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 0/Enrollment	296 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Screening	303 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Screening	7.50 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 112	6.40 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 168	6.10 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 168	296 1000 cells/cubic mm
Group 4: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 0/Enrollment	6.20 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 168	297 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Screening	6.37 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Screening	297 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 0/Enrollment	273 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 112	290 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 0/Enrollment	6.28 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 112	5.95 1000 cells/cubic mm
Group 5: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 168	6.73 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 168	291 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Screening	253 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 112	5.89 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 168	6.38 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 0/Enrollment	271 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Day 0/Enrollment	5.63 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	Platelets (1000 cells/cubic mm)- Day 112	284 1000 cells/cubic mm
Group 6: Vaccine	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm	WBC (1000 cells/cubic mm)- Screening	5.46 1000 cells/cubic mm

Primary

Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells

Level of ID50 and ID80 titer data from the TZMbl neutralizing antibody assays against 1 bnAb-specific virus (CH505TF.N334S.N160A.N280D.1, sensitive to PGT121, resistant to VRC07) for all Part A participants (IV or SC administration of PGT121.414.LS alone), and 1 bnAb-specific virus (CNE55.N160K, sensitive to VRC07, resistant to PGT121) for all Part B participants (IV or SC administration of PGT121.414.LS in combination with VRC07523LS) at all expected timepoints.

Time frame: Day 3, Months 1, 2, 4, 6, 8, 10, 12

Population: Overall Number of Participants Analyzed- represents the number of sampled participants. Number Analyzed shows the number of participants with available nAb data after filtering for assay specific quality control criteria at each timepoint.

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-D3	2916.3 Titers
Group 1: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M4	2538.5 Titers
Group 1: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-D3	6832.5 Titers
Group 1: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M4	712.2 Titers
Group 1: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M2	3890.8 Titers
Group 1: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M2	1320.9 Titers
Group 2: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M4	5465.7 Titers
Group 2: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M2	4458.1 Titers
Group 2: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M2	13658 Titers
Group 2: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-D3	9300.8 Titers
Group 2: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-D3	25726 Titers
Group 2: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M4	2144.3 Titers
Group 3: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M2	36244.6 Titers
Group 3: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M4	18205.1 Titers
Group 3: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M4	6949.7 Titers
Group 3: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M2	12014.8 Titers
Group 3: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-D3	116600.9 Titers
Group 3: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-D3	45841.5 Titers
Group 4: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M2	1238.9 Titers
Group 4: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-D3	1138 Titers
Group 4: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-D3	3427.7 Titers
Group 4: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M2	3448.4 Titers
Group 4: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M4	1809 Titers
Group 4: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M4	573.6 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M8	6137.5 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M1	53020.9 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M10	32718.2 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M12	39662.8 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M2	26629.7 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M4	15379 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M6	46634.1 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M8	26951.7 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M1	17845.1 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M10	13884.8 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M12	12040.2 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M2	9708.8 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M4	4439.9 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M6	17924.3 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M1	1644.8 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M10	881.4 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M12	394.1 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M2	1197.6 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M4	183.5 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M6	1088 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M8	318.2 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M1	258.6 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M10	151.9 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M12	34.9 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M2	111.9 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M4	37.4 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M6	130.5 Titers
Group 5: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M8	29 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M2	7.6 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M1	50.4 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M1	5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M10	67 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M6	5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M12	57.5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M10	5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M2	45.9 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M4	5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M4	5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M12	5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M12	1366.9 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M10	1658.2 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M1	1905.1 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M8	3378.6 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M6	7168.7 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M6	66.2 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M2	1150.6 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M4	2129.6 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M2	3259.5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M12	6546.9 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M10	5772.9 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID80-M8	5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M4	555.2 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CNE55.N160K-ID50-M8	15.8 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M6	1803.7 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID50-M1	5686.5 Titers
Group 6: Vaccine	Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells	CH505TF.N334S.N160A.N280D.1-ID80-M8	1074.3 Titers

Primary

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

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

Time frame: Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Mild	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	None	10 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	None	10 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	None	10 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Mild	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Mild	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Moderate	2 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Mild	4 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	None	4 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Moderate	2 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	None	4 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	None	4 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Moderate	2 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Induration/Swelling	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Mild	4 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Mild	4 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema and/or Induration	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Erythema/Redness	Severe	0 Participants

Primary

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

Time frame: Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	None	4 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Mild	4 Participants
Group 5: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Moderate	2 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	None	3 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Mild	7 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Moderate	0 Participants

Primary

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, Version 2.1 \[July 2017\]. 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 Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant

Time frame: Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Mild	1 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	None	2 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	None	3 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	None	2 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Potentially Life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Mild	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Mild	1 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Moderate	0 Participants
Group 1: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Mild	2 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	None	1 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Mild	2 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	None	1 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	None	2 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Mild	1 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Potentially Life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Mild	0 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	None	3 Participants
Group 2: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	None	2 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Mild	1 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	None	1 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Mild	2 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	None	1 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Mild	2 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Potentially Life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	None	3 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Mild	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Moderate	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Severe	0 Participants
Group 3: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Mild	1 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	None	2 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Mild	1 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Mild	1 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	None	2 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Potentially Life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Mild	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	None	2 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	None	3 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	None	10 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	None	3 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	None	10 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	None	8 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Mild	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Mild	4 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Mild	2 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Mild	2 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	None	2 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Mild	5 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	None	8 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	None	7 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	None	8 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Mild	3 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Mild	2 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Moderate	2 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Moderate	3 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Potentially Life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Moderate	2 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Mild	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	None	10 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Mild	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	None	4 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Moderate	0 Participants
Group 5: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Mild	5 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Moderate	1 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	None	9 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	None	9 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	None	8 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Mild	4 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	None	10 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	None	10 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Moderate	1 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	None	10 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Mild	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Mild	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	Mild	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Mild	4 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Mild	2 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Urticaria	None	10 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	None	5 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Headache	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Generalized Pruritus	Potentially Life-threatening	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	Mild	1 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Malaise and/or fatigue	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Chills	Mild	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Arthralgia	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Max. Systemic Symptoms	None	5 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Temperature	Mild	1 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Myalgia	None	9 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Moderate	0 Participants
Group 6: Vaccine	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Nausea	Mild	1 Participants

Primary

Number of Participants Reporting Unsolicited Adverse Events (AEs)

The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm

Time frame: Measured through Month 24

Population: Max severity reported per participant over visit

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Moderate	1 Participants
Group 1: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Potentially life-threatening	0 Participants
Group 1: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Severe	0 Participants
Group 1: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	No AE reported	0 Participants
Group 1: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Mild	2 Participants
Group 2: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Potentially life-threatening	0 Participants
Group 2: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Moderate	0 Participants
Group 2: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Severe	0 Participants
Group 2: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Mild	2 Participants
Group 2: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	No AE reported	1 Participants
Group 3: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	No AE reported	1 Participants
Group 3: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Mild	1 Participants
Group 3: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Potentially life-threatening	0 Participants
Group 3: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Moderate	1 Participants
Group 3: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Moderate	0 Participants
Group 4: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Severe	0 Participants
Group 4: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	No AE reported	1 Participants
Group 4: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Potentially life-threatening	0 Participants
Group 4: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Mild	2 Participants
Group 5: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Mild	2 Participants
Group 5: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Moderate	6 Participants
Group 5: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Severe	0 Participants
Group 5: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Potentially life-threatening	0 Participants
Group 5: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	No AE reported	2 Participants
Group 6: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Severe	0 Participants
Group 6: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Moderate	8 Participants
Group 6: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Mild	0 Participants
Group 6: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	No AE reported	2 Participants
Group 6: Vaccine	Number of Participants Reporting Unsolicited Adverse Events (AEs)	Potentially life-threatening	0 Participants

Primary

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

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

Time frame: Measured through Month 8

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Participant unable to adhere to visit schedule	0 Participants
Group 1: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Unsolicited adverse event	0 Participants
Group 1: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	PSRT decision	0 Participants
Group 1: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Did not discontinue SPA	3 Participants
Group 2: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	PSRT decision	0 Participants
Group 2: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Unsolicited adverse event	0 Participants
Group 2: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Participant unable to adhere to visit schedule	0 Participants
Group 2: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Did not discontinue SPA	3 Participants
Group 3: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Did not discontinue SPA	3 Participants
Group 3: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	PSRT decision	0 Participants
Group 3: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Unsolicited adverse event	0 Participants
Group 3: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Participant unable to adhere to visit schedule	0 Participants
Group 4: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Participant unable to adhere to visit schedule	0 Participants
Group 4: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Did not discontinue SPA	3 Participants
Group 4: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Unsolicited adverse event	0 Participants
Group 4: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	PSRT decision	0 Participants
Group 5: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	PSRT decision	0 Participants
Group 5: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Did not discontinue SPA	7 Participants
Group 5: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Unsolicited adverse event	3 Participants
Group 5: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Participant unable to adhere to visit schedule	0 Participants
Group 6: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Unsolicited adverse event	0 Participants
Group 6: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	PSRT decision	1 Participants
Group 6: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Did not discontinue SPA	8 Participants
Group 6: Vaccine	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation	Participant unable to adhere to visit schedule	1 Participants

Primary

Number of Participants With Early Study Termination and Reason for Early Study Termination

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

Time frame: Measured through Month 16

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Unable to contact participant	0 Participants
Group 1: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Participant unable to adhere to visit schedule	0 Participants
Group 1: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Scheduled exit visit/end of study	3 Participants
Group 2: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Unable to contact participant	0 Participants
Group 2: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Participant unable to adhere to visit schedule	0 Participants
Group 2: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Scheduled exit visit/end of study	3 Participants
Group 3: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Unable to contact participant	0 Participants
Group 3: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Participant unable to adhere to visit schedule	0 Participants
Group 3: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Scheduled exit visit/end of study	3 Participants
Group 4: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Unable to contact participant	0 Participants
Group 4: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Participant unable to adhere to visit schedule	0 Participants
Group 4: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Scheduled exit visit/end of study	3 Participants
Group 5: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Unable to contact participant	1 Participants
Group 5: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Participant unable to adhere to visit schedule	1 Participants
Group 5: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Scheduled exit visit/end of study	8 Participants
Group 6: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Participant unable to adhere to visit schedule	0 Participants
Group 6: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Scheduled exit visit/end of study	9 Participants
Group 6: Vaccine	Number of Participants With Early Study Termination and Reason for Early Study Termination	Unable to contact participant	1 Participants

Primary

PGT121.414.LS and VRC07523LS Serum Concentrations

Serum concentrations of PGT121.414.LS and VRC07-523LS at prespecified timepoints among participants who received all scheduled product administrations

Time frame: Days 0, 0.0417, 1, 2, 3, 6, 14, 28, 56, 84, 112, 112.0417, 140, 168, 196, 224, 224.0417, 252, 280, 336, 392, 448

Population: Overall Number of Participants Analyzed represents the number of enrolled participants. Number Analyzed shows the number of participants with available data after filtering for assay specific quality control criteria at each timepoint.

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D6	34.93493 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D14	33.50825 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D28	24.41258 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0.0417	63.83584 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D168	6.985977 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D224	4.546627 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D1	57.19892 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D3	42.63419 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0	0.32666 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D2	47.33316 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112	12.18623 ug/ml
Group 1: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D56	20.04609 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D3	135.5188 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D1	164.7475 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D14	93.52175 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D56	59.34368 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D168	17.03774 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D2	146.6062 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0	0.09765 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0.0417	221.7834 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D28	86.60540 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D224	11.50982 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D6	126.4765 ug/ml
Group 2: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112	31.38540 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D224	51.03267 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0	0.09765 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D3	496.2948 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D6	404.6015 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D28	250.3132 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D1	525.8889 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112	113.6597 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D14	287.3416 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D56	185.9332 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D168	70.64411 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0.0417	554.8116 ug/ml
Group 3: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D2	501.1791 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D168	6.447051 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D28	22.88940 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D6	24.72877 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0.0417	0.09765 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112	10.28579 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0	0.09765 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D1	15.57179 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D3	21.51805 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D56	19.82906 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D14	27.97899 ug/ml
Group 4: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D2	19.73051 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D224	100.3895 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0	0.09765 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0.0417	714.2483 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D1	540.5799 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112	91.12431 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112.0417	866.2283 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D14	250.1545 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D140	274.8957 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D168	196.5922 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D196	131.9651 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D224.0417	858.8545 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D252	300.5559 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D28	218.4120 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D280	190.1484 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D3	328.0125 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D336	122.0257 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D392	69.69947 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D448	53.10780 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D56	152.5493 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D6	308.2920 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D84	118.2193 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D0	0.02285 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D0.0417	630.4643 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D1	407.5692 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D112	35.65999 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D112.0417	686.4594 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D14	143.4822 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D140	122.3509 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D168	85.35126 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D196	57.95509 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D224	37.81075 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D224.0417	743.0381 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D252	144.2619 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D28	102.0101 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D280	78.68985 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D3	206.2347 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D336	36.82022 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D392	18.29589 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D448	7.518283 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D56	68.61530 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D6	168.2826 ug/ml
Group 5: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D84	49.01481 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D224.0417	6.425585 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D0.0417	0.198904 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D336	8.174529 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D252	21.76401 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D112	4.320423 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D56	11.10549 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D112.0417	4.605856 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D28	15.30037 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D14	18.69117 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D392	4.050364 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D280	39.22639 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D28	38.72047 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D252	49.82065 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D224.0417	19.81756 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D224	20.24181 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D140	21.86040 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D3	43.11783 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D280	13.66478 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D336	25.60772 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D168	16.51087 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D392	14.40051 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D84	7.679106 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D196	30.01136 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D168	40.64268 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D140	53.56555 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D14	45.60168 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D196	11.16378 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D56	29.33043 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112.0417	13.15082 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D112	14.53687 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0.0417	0.868341 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D0	0.09765 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D3	21.27877 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D6	44.67182 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D224	6.780613 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	PGT121.414.LS-D84	22.61336 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D6	21.24964 ug/ml
Group 6: Vaccine	PGT121.414.LS and VRC07523LS Serum Concentrations	VRC07-523LS-D0	0.02285 ug/ml

Secondary

Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9

Magnitude-breadth characterize the magnitude (ID50 or ID80 titers) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the fraction of assays with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) is calculated as the average of the log10-based ID50 or ID80 titers over the panel of isolates. Isolates includes: 0330.v4.c3, 3426.v5.c17, 377.v4.c09, AC10.0.29, Ce1176\_A3, DU156.12, DU172.17, PVO.4, RHPA4259.7, SC422661.8, T2638, andTRO.11.

Time frame: Months 1, 4, and 9

Population: Overall Number of Participants Analyzed presents the number of enrolled participants in each treatment arm. Number Analyzed shows the number of samples available and tested in a certain tier and timepoint.

Arm	Measure	Group	Value (MEDIAN)
Group 1: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M1	2.87 log10(titer)
Group 1: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M4	2.54 log10(titer)
Group 1: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M1	2.28 log10(titer)
Group 1: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M4	1.89 log10(titer)
Group 2: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M1	2.84 log10(titer)
Group 2: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M4	3.08 log10(titer)
Group 2: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M1	3.39 log10(titer)
Group 2: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M4	2.36 log10(titer)
Group 3: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M4	2.88 log10(titer)
Group 3: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M1	3.36 log10(titer)
Group 3: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M4	3.55 log10(titer)
Group 3: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M1	4 log10(titer)
Group 4: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M1	2.79 log10(titer)
Group 4: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M4	1.81 log10(titer)
Group 4: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M4	2.42 log10(titer)
Group 4: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M1	2.23 log10(titer)
Group 5: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M1	3.46 log10(titer)
Group 5: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M9	3.62 log10(titer)
Group 5: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M9	4.12 log10(titer)
Group 5: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M1	3.97 log10(titer)
Group 6: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M9	3.2 log10(titer)
Group 6: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M1	2.47 log10(titer)
Group 6: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID80-M9	2.66 log10(titer)
Group 6: Vaccine	Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9	ID50-M1	3.02 log10(titer)

Secondary

Occurrence of Antidrug Antibodies (ADA)

Antidrug antibodies (ADA) are most typically detected and characterized using a tiered testing strategy. In Tier I, a sensitive binding assay is used to determine if samples may have ADA present. In Tier II, the response is confirmed, typically by establishing the specificity of the response by competition with free drug. In Tier III, the response is characterized, typically with a neutralization reduction assay and/or a titering assay.

Time frame: Day 0, 112, 196, 224, 336, 392, 448

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D112	0 Participants
Group 1: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D224	0 Participants
Group 1: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D0	0 Participants
Group 2: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D112	0 Participants
Group 2: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D224	0 Participants
Group 2: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D0	0 Participants
Group 3: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D0	0 Participants
Group 3: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D112	0 Participants
Group 3: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D224	0 Participants
Group 4: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D0	0 Participants
Group 4: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D112	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier II-D0	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D0	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D112	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D196	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D224	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D336	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D392	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D448	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D0	1 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D112	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D196	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D224	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D336	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D392	0 Participants
Group 5: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D448	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D392	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D196	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D112	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D112	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D224	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D336	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D336	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D196	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D392	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	PGT121.414.LS-Tier I-D0	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D224	0 Participants
Group 6: Vaccine	Occurrence of Antidrug Antibodies (ADA)	VRC07-523LS-Tier I-D0	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026

Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L

Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL

Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL

Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm

Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm

Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells

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

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

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Number of Participants Reporting Unsolicited Adverse Events (AEs)

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

Number of Participants With Early Study Termination and Reason for Early Study Termination

PGT121.414.LS and VRC07523LS Serum Concentrations

Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9

Occurrence of Antidrug Antibodies (ADA)