Trial Outcomes & Findings for Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults (NCT NCT03783130)

Last Updated: 2021-08-12

Results Overview

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each 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 U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

7 days after study product administration, at approximately Week 1, Week 9 and Week 21

Results posted on

2021-08-12

Participant Flow

Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.

Participant milestones

Participant milestones
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.
Overall Study STARTED	3	3	5	5
Overall Study Received All Product Administrations	3	3	5	5
Overall Study COMPLETED	3	3	5	5
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Total n=16 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 12.7 • n=5 Participants	35.7 years STANDARD_DEVIATION 12.5 • n=7 Participants	32.4 years STANDARD_DEVIATION 8.1 • n=5 Participants	32.4 years STANDARD_DEVIATION 10.9 • n=4 Participants	33.0 years STANDARD_DEVIATION 9.7 • n=21 Participants
Age, Customized 21-30 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
Age, Customized 31-40 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Age, Customized 41-50 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Body Mass Index (BMI) Under 18.5 kg/m^2	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Body Mass Index (BMI) 18.5-24.9 kg/m^2	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Body Mass Index (BMI) 25.0-29.9 kg/m^2	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Body Mass Index (BMI) 30.0 kg/m^2 or over	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: 7 days after study product administration, at approximately Week 1, Week 9 and Week 21

Population: Population included all enrolled participants who received at least one study product administration and provided safety data (via diary card and/or laboratory results) following study product administration. All participants completed the study product administration schedule per protocol.

Outcome measures

Outcome measures
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Overall Incidence Trimer 4571 (100 mcg and 500 mcg) n=16 Participants Trimer 4571 dose groups included adults who received either three doses of 100 mcg or three doses of 500 mcg of Trimer 4571 with 500 mcg of alum field mixed administered intramuscularly (IM), or administered subcutaneously (SC) on Day 0, Week 8, and Week 20
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Pain/Tenderness · None	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Pain/Tenderness · Mild	2 Participants	2 Participants	5 Participants	5 Participants	14 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Pain/Tenderness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Pain/Tenderness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Swelling · None	3 Participants	1 Participants	4 Participants	4 Participants	12 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Swelling · Mild	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Swelling · Moderate	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Swelling · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Redness · None	3 Participants	1 Participants	4 Participants	3 Participants	11 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Redness · Mild	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Redness · Moderate	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Redness · Severe	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Bruising · None	3 Participants	3 Participants	5 Participants	5 Participants	16 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Bruising · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Bruising · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Bruising · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Any Local Symptom · None	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Any Local Symptom · Mild	2 Participants	0 Participants	4 Participants	4 Participants	10 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Any Local Symptom · Moderate	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 7 days after study product administration, at approximately Week 1, Week 9 and Week 21

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the 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 U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.

Outcome measures

Outcome measures
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Overall Incidence Trimer 4571 (100 mcg and 500 mcg) n=16 Participants Trimer 4571 dose groups included adults who received either three doses of 100 mcg or three doses of 500 mcg of Trimer 4571 with 500 mcg of alum field mixed administered intramuscularly (IM), or administered subcutaneously (SC) on Day 0, Week 8, and Week 20
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Chills · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Chills · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Chills · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Nausea · None	3 Participants	2 Participants	5 Participants	4 Participants	14 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Nausea · Mild	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Nausea · Moderate	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Nausea · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Temperature · None	3 Participants	3 Participants	5 Participants	5 Participants	16 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Temperature · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Any Systemic Symptom · None	2 Participants	1 Participants	0 Participants	2 Participants	5 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Any Systemic Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Malaise · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Malaise · None	3 Participants	2 Participants	3 Participants	3 Participants	11 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Malaise · Mild	0 Participants	0 Participants	2 Participants	2 Participants	4 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Malaise · Moderate	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Myalgia · None	2 Participants	3 Participants	1 Participants	4 Participants	10 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Myalgia · Mild	1 Participants	0 Participants	4 Participants	1 Participants	6 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Myalgia · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Myalgia · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Headache · None	2 Participants	1 Participants	4 Participants	4 Participants	11 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Headache · Mild	1 Participants	2 Participants	1 Participants	1 Participants	5 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Headache · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Headache · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Chills · None	3 Participants	3 Participants	5 Participants	5 Participants	16 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Temperature · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Temperature · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Any Systemic Symptom · Mild	1 Participants	1 Participants	5 Participants	3 Participants	10 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration Any Systemic Symptom · Moderate	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Through 40 weeks after the first study product administration

Population: Population included all enrolled participants who had laboratory results available at any study visit post baseline.

Any abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Labs included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) with differential, creatine and ALT results were collected at screening, Day 0 prior to the first study product administration (baseline), and Weeks 1-2 after the 1st administration, Week 8 (2nd product administration), and Weeks 9-10 after the 2nd administration, Week 20 (3rd product administration), and Weeks 21-22 after the 3rd administration. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.

Outcome measures

Outcome measures
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Overall Incidence Trimer 4571 (100 mcg and 500 mcg) n=16 Participants Trimer 4571 dose groups included adults who received either three doses of 100 mcg or three doses of 500 mcg of Trimer 4571 with 500 mcg of alum field mixed administered intramuscularly (IM), or administered subcutaneously (SC) on Day 0, Week 8, and Week 20
Number of Participants With Abnormal Laboratory Measures of Safety ALT	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Measures of Safety Neutrophil count	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Through 28 days after each study product administration, up to Week 24

Unsolicited AEs and attribution assessments were recorded in the study database from receipt of each study product administration through the visit scheduled at 28 days (or 4 weeks) after each study product administration. At other time periods greater than the 28-day (or 4-week) post product administration visit, only serious AEs (SAEs reported as a separate outcome and in the AE module), and new chronic medical conditions that required ongoing medical management 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. If a participant had several AEs and some were evaluated as related and some as unrelated to study product, the participant is counted once as having the related event.

Outcome measures

Outcome measures
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Overall Incidence Trimer 4571 (100 mcg and 500 mcg) n=16 Participants Trimer 4571 dose groups included adults who received either three doses of 100 mcg or three doses of 500 mcg of Trimer 4571 with 500 mcg of alum field mixed administered intramuscularly (IM), or administered subcutaneously (SC) on Day 0, Week 8, and Week 20
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Related to Study Product	0 Participants	2 Participants	3 Participants	2 Participants	7 Participants
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Unrelated to Study Product	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Through 40 weeks after the first study product administration

SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 40. 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.

Outcome measures

Outcome measures
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Overall Incidence Trimer 4571 (100 mcg and 500 mcg) n=16 Participants Trimer 4571 dose groups included adults who received either three doses of 100 mcg or three doses of 500 mcg of Trimer 4571 with 500 mcg of alum field mixed administered intramuscularly (IM), or administered subcutaneously (SC) on Day 0, Week 8, and Week 20
Number of Participants With Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline through Study Week 22, at 14 days after the final study product administration.

Population: Population included all enrolled participants who received three study product administrations per protocol.

Trimer 4571-specific antibody titers were measured by Electrochemiluminescence (ECLIA) using a Meso Scale Discovery (MSD) platform. Serum samples collected at baseline and at 2 weeks after the third product administration were tested in the assay. Since there is no standard/calibration curve available for interpolation of this raw response, area under the curve (AUC) was calculated for each serum sample tested in the 8-fold serial dilutions. The AUC measurement is calculated for each single timepoint sample (baseline or week 22, 2 weeks after the final vaccination). The AUC is calculated with Graphpad Prism™ using the trapezoid rule from the raw sample response (ECL response) over an 8-fold dilution series (Dilution Factor) for each sample. Group geometric mean AUCs and 95% Confidence Intervals are reported.

Outcome measures

Outcome measures
Measure	Group 1: Trimer 4571 (100 mcg) IM With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 2: Trimer 4571 (100 mcg) SC With Alum n=3 Participants Trimer 4571 injections (100 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 3: Trimer 4571 (500 mcg) IM With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered intramuscularly (IM) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Group 4: Trimer 4571 (500 mcg) SC With Alum n=5 Participants Trimer 4571 injections (500 mcg), with 500 mcg of alum field mixed, administered subcutaneously (SC) in a 1 mL volume by Needle/Syringe on Day 0, Week 8, and Week 20 VRC-HIVRGP096-00-VP: Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding. Alum Adjuvant: Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.	Overall Incidence Trimer 4571 (100 mcg and 500 mcg) Trimer 4571 dose groups included adults who received either three doses of 100 mcg or three doses of 500 mcg of Trimer 4571 with 500 mcg of alum field mixed administered intramuscularly (IM), or administered subcutaneously (SC) on Day 0, Week 8, and Week 20
Antibody Response to Adjuvanted Trimer 4571 at 2 Weeks After the Final Study Product Administration Antibody Response to Adjuvanted Trimer 4571 at 2 Weeks after the Final Study Product Administration	674 AUC (ECL response units/Dilution Factor) Interval 50.0 to 9011.0	924 AUC (ECL response units/Dilution Factor) Interval 175.0 to 4880.0	2529 AUC (ECL response units/Dilution Factor) Interval 387.0 to 16515.0	1368 AUC (ECL response units/Dilution Factor) Interval 551.0 to 3397.0	—
Antibody Response to Adjuvanted Trimer 4571 at 2 Weeks After the Final Study Product Administration Antibody Response at Baseline	81 AUC (ECL response units/Dilution Factor) Interval 40.0 to 163.0	53 AUC (ECL response units/Dilution Factor) Interval 17.0 to 169.0	62 AUC (ECL response units/Dilution Factor) Interval 25.0 to 151.0	50 AUC (ECL response units/Dilution Factor) Interval 26.0 to 97.0	—

Adverse Events

Group 1: Trimer 4571 (100 mcg) IM With Alum

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 2: Trimer 4571 (100 mcg) SC With Alum

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 3: Trimer 4571 (500 mcg) IM With Alum

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 4: Trimer 4571 (500 mcg) SC With Alum

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Martin Gaudinski, MD

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health

Phone: 301-451-8715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place