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HVTN 124

Status
Ongoing
Phase
I
Objective

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Arms and Assigned Interventions
Description
Participants will receive 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant at Day 0 and Month 2.
Mode of Delivery
Intramuscular
Products
gp120 (A,B,C,A/E)/GLA-SE
ARMs
Experimental
Clade
A
B
C
E
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Participants will receive 2 mg of env (A,B,C,A/E)/gag (C) DNA vaccine and placebo at Day 0 and Months 1 and 3. Participants will receive 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant and a placebo vaccine at Months 6 and 8.
Mode of Delivery
Intramuscular
Products
env (A,B,C,A/E)/gag (C)/GLA-SE
gp120 (A,B,C,A/E)/GLA-SE
ARMs
Experimental
Clade
A
B
C
E
Description
Participants will receive placebo at Day 0 and Months 1, 3, 6, and 8.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Participants will receive 2 mg of the env (A,B,C,A/E)/gag (C) DNA vaccine and 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant at Day 0 and Months 1, 3, 6, and 8.
Mode of Delivery
Intramuscular
Products
env (A,B,C,A/E)/gag (C)/GLA-SE
gp120 (A,B,C,A/E)/GLA-SE
ARMs
Experimental
Clade
A
B
C
E
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
DAIDS
February 2018
October 2020
Enrollment
60
18
Years
50
Years
Population
Women
Men
Sites

University of Alabama at Birmingham

Birmingham, Alabama
United States of America

Site(s) - Cleveland

Cleveland, OH
United States of America

Site(s) - Boston

Massachusetts
United States of America

Site(s) - Philadelphia

Philadelphia, Pennsylvania
United States of America