Evaluating the Safety and Immunogenicity of Polyvalent DNA and Recombinant gp120 Protein HIV Vaccine (PDPHV) in Healthy, HIV-uninfected Adults

Phase 2 Not yet recruiting 126 enrolled Worcester HIV Vaccine Brigham and Women's Hospital · collab Desmond Tutu Health Foundation · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA prime and gp120 (A,B,C,A/E) protein HIV-1 vaccines boost (PDPHV) with either Alhydrogel or GLA-SE in healthy, HIV-uninfected adults. Volunteers will receive either the PDPHV or the placebo (normal saline) by intramuscular injections. Some volunteers will receive Alhydrogel and others will receive GLA-SE as part of the protein boost.

Timeline

Start: 2026-09-01
Primary completion: 2028-08-31
Completion: 2029-08

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alhydrogel adjuvant	Unknown	0.8 mg	Intramuscular
Subject	GLA-SE	Other / unclassified	0.005 mg	Intramuscular
Subject	PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C))	Vaccine	2 mg	Intramuscular
Subject	PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E))	Vaccine	0.4 mg	Intramuscular

Indications

No indication recorded.