MedTrace Logo

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

NCT07675629 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

  • HIV Prevention

Interventions

BIOLOGICAL

PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C))

The polyvalent DNA Vaccines contains equal amounts of 5 individual DNA plasmid components utilizing the same vector pSW3891. Four plasmids each containing a codon optimized gp120 gene sequence from HIV-1 subtype A, B, C and CRF01\_AE consensus, and a fifth plasmid containing a codon optimized gag gene from subtype C.

BIOLOGICAL

PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E))

The Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) contains equal amounts of 4 gp120 proteins.

BIOLOGICAL

Alhydrogel adjuvant

PDPHV protein vaccines adjuvant

BIOLOGICAL

GLA-SE adjuvant

PDPHV protein vaccines adjuvant

BIOLOGICAL

Placebo for DNA Vaccines, Protein Vaccines and Adjuvants

Sodium Chloride for Injection, USP 0.9%.

Sponsors & Collaborators

  • Desmond Tutu Health Foundation

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Worcester HIV Vaccine

    lead INDUSTRY

Principal Investigators

  • Conasagrie Nair, PhD, MD · Desmond Tutu Health Foundation

  • Stephen Walsh, PhD, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675629 on ClinicalTrials.gov