WHV 138
Status:Ongoing
Phase:I
Principal Investigator(s):Shan Lu
Objective:The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein vaccines (PDPHV201401) co-administered together with or without adjuvant in repeated doses in healthy, HIV-uninfected adults.An earlier version of this vaccine was tested in a single-site clinical trial conducted at UMass Medical School, and the second generation of the vaccine has been recently tested at six U.S. sites by the HIV Vaccine Trials Network under protocol HVTN 124. Last updated September 16, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Group 1 (Treatment): DNA Vaccine + Protein Vaccine/GLA-SE
Participants will receive 2 mg of 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 3, 6, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Group 2 (Treatment): Admixture of DNA Vaccine and Protein Vaccine
Participants will receive admixture of 2 mg of env (A,B,C,A/E)/gag (C) DNA vaccine and 400 mcg of gp120 (A,B,C,A/E) protein vaccine (no adjuvant) at Day 0, and Months 1, 3, 6, and 8.
Mode of DeliveryIntramuscular
ARMsPlacebo Comparator
Official Code:
NCT04927585
Trial Sponsors:
IDRI, LLC, NIAID, Target Health, Worcester HIV Vaccine
Start Date
End Date
July 8, 2021
December 2, 2023
Enrollment:42
Age range:
18 Years ↔
50 Years
Population:Cisgender Men