A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults

VRC 615: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB-0115-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05627258

Enrollment

Registered

2022-11-25

Start date

2023-01-30

Completion date

2024-07-17

Last updated

2025-08-22

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

Conditions

HIV

Keywords

Monoclonal Antibody, CD4 Binding, HIV envelope, First in Human, Broadly Neutralizing

Brief summary

Background: HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it. Antibodies may offer a promising new way to prevent HIV infection. Antibodies are proteins that are naturally made by the body to fight germs. One antibody (VRC01.23LS) has been tested in the lab and was found to block HIV-like viruses. Researchers want to find out if it is safe to inject VRC01.23LS into people. Objective: To test the safety of VRC01.23LS in healthy adults. Eligibility: Healthy people aged 18 to 60 years. Design: Participants were divided into 6 groups: Some got 1 dose of VRC01.23LS. They visited the clinic up to 14 times in 24 weeks. Some got 3 doses, each 12 weeks apart. They had 25 clinic visits over 48 weeks. For some participants, the drug was given through a tube attached to a needle inserted into a vein in the arm. This took about 30 to 90 minutes. Others received the drug as an injection under the skin in a fatty area of the belly, arm, or thigh; each dose may have needed up to 3 individual injections. Participants stayed in the clinic up to 8 hours on the days they received VRC01.23LS. Participants received a thermometer and measuring tool. They checked their temperature daily for 7 days after they received the study drug. They measured any redness, swelling, or bruising at the injection site.

Detailed description

Study Design: This first-in-human, open-label study evaluated VRC01.23LS (VRCHIVMAB0115- 00-AB) in a dose-escalation design to examine safety, tolerability, dose, and pharmacokinetics (PK) in healthy adults. The primary hypothesis was that subcutaneous (SC) and intravenous (IV) administrations of VRC01.23LS will be safe and well-tolerated in healthy adults. A secondary hypothesis was that VRC01.23LS will be detectable in human sera with a definable half-life. Study Products: The VRC01.23LS broadly neutralizing monoclonal antibody (bnAb) targets the CD4 binding site in the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve the antibody half-life in vivo. VRC01.23LS was developed by the VRC/NIAID/NIH and manufactured under cGMP regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick. MD. Subjects: Healthy adults, 18-60 years of age Study Plan: This open-label study included 6 groups to evaluate VRC01.23LS administered as a single dose or as repeated doses, given 12 weeks apart as shown in the table below. Enrollment began with the 5 mg/kg dose groups, and enrollment in subsequent dose groups proceeded after dose-escalation safety reviews. Assessment of safety included solicited reactogenicity, clinical observation, and monitoring of hematological and metabolic parameters at clinical visits throughout the study.

Interventions

BIOLOGICALVRC-HIVMAB0115-00-AB

VRC01.23LS, a broadly neutralizing monoclonal antibody targeting the HIV-1 envelope CD4 binding site.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* INCLUSION CRITERIA: A subject must meet all of the following criteria: 1. Willing and able to complete the informed consent process. 2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 3. Available for clinical follow-up through the last study visit. 4. 18 to 60 years of age. 5. In good general health without clinically significant medical history. 6. Physical examination without clinically significant findings within the 56 days prior to enrollment. 7. Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to SC group. 8. Willing to have blood samples collected, stored indefinitely, and used for research purposes. Laboratory Criteria within 56 days prior to enrollment: 9. White blood cell count (WBC): 2,500-12,000/mm3. 10. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval. 11. Platelets: 125,000 - 500,000/mm3. 12. Hemoglobin within institutional normal range or accompanied by PI or designee approval. 13. Creatinine: \<= 1.1 x Upper Limit of Normal (ULN). 14. ALT: \<= 1.25 x ULN. 15. AST: \<= 1.25 x ULN. 16. Negative for HIV infection by an FDA approved method of detection. Female-Specific Criteria: 17. Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation. 18. Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

Exclusion criteria

A subject will be excluded if one or more of the following conditions apply: 1. Woman who is breast-feeding or planning to become pregnant during study participation. 2. Weight \> 115 kg. 3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study. 4. Hypertension that is not well controlled. 5. Receipt of any investigational study product within 28 days prior to enrollment (Note: Emergency Use Authorization of a COVID-19 vaccine is not exclusionary). 6. Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody. 7. Receipt of any live attenuated vaccine within 28 days prior to enrollment. 8. Receipt of any vaccine within 2 weeks prior to enrollment. 9. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. 10. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, infectious disease, autoimmune disease, psychiatric disorder, heart disease, or cancer.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With New Chronic Medical Conditions Following Product Administration	Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48 for Groups 5-6	New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 24 for Groups 1-4 and through Week 48 for Groups 5-6. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	7 days after product administration	Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for Groups 5-6	Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 - July 2017 were used.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	7 days after product administration	Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017
Number of Participants With Serious Adverse Events Following Product Administration	Day 0 after product administration through Day 168, up to Week 24 for participants in Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for participants in Group 5 and 6.	SAEs were recorded from receipt of product administration through the last study visit at Week 24 for participants in Groups 1, 2, 3, 4. SAEs were recorded from receipt of product administration through the last study visit at Week 48 for participants in Groups 5 or 6. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Day 0 through 28 days post product administration, up to Week 4	Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Secondary

Measure	Time frame	Description
Pharmacokinetic (PK) Parameters of VRC01.23LS: Time to Reach Maximum Observed Serum Concentration (Tmax)	Baseline through 24 weeks after VRC01.23LS product administration	Tmax is the time it takes to reach Cmax of VRC01.23LS after it has been administered; it is determined based on the summary PK curve for each dose group.
Pharmacokinetic (PK) Parameters of VRC01.23LS: Beta Half-life (T1/2b)	Baseline through 24 weeks after VRC01.23LS product administration	Beta half-life (T1/2b) is the time required for half of the VRC01.23LS product to be eliminated from the serum.
Pharmacokinetic (PK) Parameters of VRC01.23LS: Clearance Rate	Baseline through 24 weeks after VRC01.23LS product administration	Clearance is the rate of VRC01.23LS elimination divided by the plasma VRC01.23LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F).
Pharmacokinetic (PK) Parameters of VRC01.23LS: Volume of Distribution	Baseline through 24 weeks after VRC01.23LS product administration	Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F).
Pharmacokinetic (PK) Parameters of VRC01.23LS: Maximum Observed Serum Concentration (Cmax)	Baseline through 24 weeks after VRC01.23LS product administration	Cmax is the peak serum concentration that VRC01.23LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group 1 VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration	4
Group 2 VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration	3
Group 3 VRC-HIVMAB0115-00-AB: VRC01.23LS- 20 mg/kg IV single administration	3
Group 4 VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration	3
Group 5 VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing:3 times, 12 weeks apart	5
Group 6 VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times, 12 weeks apart	5
Total	23

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG004
Overall Study	Enrolled, but product not administered	1	0	0
Overall Study	Lost to Follow-up	1	0	0
Overall Study	Other subject illness/injury	1	0	0
Overall Study	Subject moved from area	0	1	0
Overall Study	Withdrawal by Subject	0	0	2

Baseline characteristics

Characteristic	Group 2	Group 3	Group 4	Group 1	Group 5	Group 6	Total
Age, Continuous	44.3 years STANDARD_DEVIATION 7.1	21.3 years STANDARD_DEVIATION 0.6	28.7 years STANDARD_DEVIATION 12.2	28.3 years STANDARD_DEVIATION 3.2	26.2 years STANDARD_DEVIATION 4.3	29.6 years STANDARD_DEVIATION 5.6	29.3 years STANDARD_DEVIATION 8.4
Age, Customized AGE Ages 18-20	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Age, Customized AGE Ages 21-30	0 Participants	3 Participants	1 Participants	3 Participants	4 Participants	2 Participants	13 Participants
Age, Customized AGE Ages 31-40	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	6 Participants
Age, Customized AGE Ages 41-60	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Education Advanced degree	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	5 Participants
Education College/University	2 Participants	3 Participants	1 Participants	4 Participants	3 Participants	3 Participants	16 Participants
Education High school graduate/GED	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Education Less than a high school graduate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Education Not Collected	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants	2 Participants	2 Participants	3 Participants	5 Participants	5 Participants	19 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	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	4 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 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	1 Participants	1 Participants	2 Participants	2 Participants	3 Participants	4 Participants	13 Participants
Sex: Female, Male Female	1 Participants	1 Participants	2 Participants	2 Participants	2 Participants	3 Participants	11 Participants
Sex: Female, Male Male	2 Participants	2 Participants	1 Participants	2 Participants	3 Participants	2 Participants	12 Participants
Weight	82.9 kg STANDARD_DEVIATION 11.4	66.7 kg STANDARD_DEVIATION 11.7	75.2 kg STANDARD_DEVIATION 18.3	68.0 kg STANDARD_DEVIATION 16.8	81.7 kg STANDARD_DEVIATION 26.9	68.6 kg STANDARD_DEVIATION 11	73.8 kg STANDARD_DEVIATION 17.1

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 / 5	0 / 5
other Total, other adverse events	1 / 3	2 / 3	3 / 3	3 / 3	4 / 5	3 / 5
serious Total, serious adverse events	0 / 3	0 / 3	0 / 3	0 / 3	0 / 5	0 / 5

Outcome results

Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)

Time frame: 7 days after product administration

Population: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	3 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	3 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	3 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	3 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	None	3 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	3 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	2 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	2 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	2 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	2 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Mild	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	None	3 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	2 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	None	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	2 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	2 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Mild	2 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	2 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	2 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	3 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	3 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	3 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	None	3 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	3 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	3 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	2 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	3 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	1 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	1 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	3 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Moderate	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Mild	1 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	5 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	1 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	2 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	1 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Severe	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	3 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	None	4 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 5	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	3 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	None	5 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	1 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Mild	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Moderate	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Bruising	Severe	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	5 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	5 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	4 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	1 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	5 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 6	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	4 Participants

Primary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017

Time frame: 7 days after product administration

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	3 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	2 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	1 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	3 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	3 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	2 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	1 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	3 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	3 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	2 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	1 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	3 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	2 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	2 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	2 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	2 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	3 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	3 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	3 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	2 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	3 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	1 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	4 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	5 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	3 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	1 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	1 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	4 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	2 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	4 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	5 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	2 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 5	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	3 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	3 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	2 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	2 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	2 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	1 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	5 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	3 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	1 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	4 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	5 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	1 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	3 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	3 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	2 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	2 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	1 Participants
Group 6	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants

Primary

Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration

Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 - July 2017 were used.

Time frame: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for Groups 5-6

Population: Population included all enrolled participants who received study product (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Creatinine	0 Participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Bilirubin	0 Participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Number of Participants With No Abnormal lab results recorded as unsolicited adverse events (AEs)	3 Participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Creatinine	0 Participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Bilirubin	0 Participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Number of Participants With No Abnormal lab results recorded as unsolicited adverse events (AEs)	3 Participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Creatinine	0 Participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Bilirubin	0 Participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Number of Participants With No Abnormal lab results recorded as unsolicited adverse events (AEs)	3 Participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Creatinine	0 Participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Bilirubin	1 Participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Number of Participants With No Abnormal lab results recorded as unsolicited adverse events (AEs)	2 Participants
Group 5	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Creatinine	1 Participants
Group 5	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Bilirubin	0 Participants
Group 5	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Number of Participants With No Abnormal lab results recorded as unsolicited adverse events (AEs)	4 Participants
Group 6	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Bilirubin	0 Participants
Group 6	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Number of Participants With No Abnormal lab results recorded as unsolicited adverse events (AEs)	5 Participants
Group 6	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Creatinine	0 Participants

Primary

Number of Participants With New Chronic Medical Conditions Following Product Administration

New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 24 for Groups 1-4 and through Week 48 for Groups 5-6. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Time frame: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48 for Groups 5-6

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	3 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	3 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	3 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	3 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 5	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 5	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	5 Participants
Group 5	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 5	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 6	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 6	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 6	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	5 Participants
Group 6	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants

Primary

Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration

Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Time frame: Day 0 through 28 days post product administration, up to Week 4

Arm	Measure	Group	Value (NUMBER)
Group 1	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	0 participants
Group 1	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	0 participants
Group 1	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	0 participants
Group 1	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had no Unsolicited AEs	3 participants
Group 2	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	0 participants
Group 2	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	0 participants
Group 2	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	0 participants
Group 2	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had no Unsolicited AEs	3 participants
Group 3	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had no Unsolicited AEs	1 participants
Group 3	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	2 participants
Group 3	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	1 participants
Group 3	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	1 participants
Group 4	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	3 participants
Group 4	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had no Unsolicited AEs	0 participants
Group 4	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	0 participants
Group 4	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	3 participants
Group 5	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	3 participants
Group 5	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had no Unsolicited AEs	2 participants
Group 5	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	1 participants
Group 5	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	2 participants
Group 6	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	0 participants
Group 6	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	2 participants
Group 6	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had no Unsolicited AEs	3 participants
Group 6	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	2 participants

Primary

Number of Participants With Serious Adverse Events Following Product Administration

SAEs were recorded from receipt of product administration through the last study visit at Week 24 for participants in Groups 1, 2, 3, 4. SAEs were recorded from receipt of product administration through the last study visit at Week 48 for participants in Groups 5 or 6. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Time frame: Day 0 after product administration through Day 168, up to Week 24 for participants in Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for participants in Group 5 and 6.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	3 Participants
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	3 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	3 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	3 Participants
Group 5	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	5 Participants
Group 5	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 5	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 5	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 6	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	5 Participants
Group 6	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 6	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 6	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants

Secondary

Pharmacokinetic (PK) Parameters of VRC01.23LS: Beta Half-life (T1/2b)

Beta half-life (T1/2b) is the time required for half of the VRC01.23LS product to be eliminated from the serum.