Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of Polyvalent Env (A, B, C, A/E) / Gag (C) DNA and gp120 (A, B, C, A/E) Protein HIV-1 Vaccines (PDPHV) With Either Alhydrogel or GLA-SE in Healthy Adults Living Without HIV

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.

Description

Eligibility

Age range

18–55 years

Sex

All

Healthy volunteers

Yes

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%.

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