About this trial
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.
Eligibility criteria
Qualifiers
Age of 18 to 55 years
Access to a trial site and willingness to be followed for the planned duration of the study.
Ability and willingness to provide informed consent
Demonstrates an understanding of the study
Disqualifiers
Blood products received within 120 days before first vaccination.
Investigational research agents received within 30 days before first vaccination.
Body mass index (BMI) ≥ 40.
Intent to participate in another study of an investigational research agent or any other study that requires HIV antibody testing.
Trial design
Treatments tested in this trial
- PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C))
- PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E))
- Alhydrogel adjuvant
- GLA-SE adjuvant
- Placebo for DNA Vaccines, Protein Vaccines and Adjuvants
Treatment groups
10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Worcester HIV Vaccine
Lead sponsor
Desmond Tutu Health Foundation
Collaborator
Brigham and Women's Hospital
Collaborator