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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorWorcester HIV Vaccine

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

126 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Sponsors and collaborators

Worcester HIV Vaccine

Lead sponsor

Desmond Tutu Health Foundation

Collaborator

Brigham and Women's Hospital

Collaborator