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

Conditions

• HIV Prevention

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)) — BIOLOGICAL
  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.
• PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) — BIOLOGICAL
  The Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) contains equal amounts of 4 gp120 proteins.
• Alhydrogel adjuvant — BIOLOGICAL
  PDPHV protein vaccines adjuvant
• GLA-SE adjuvant — BIOLOGICAL
  PDPHV protein vaccines adjuvant
• Placebo for DNA Vaccines, Protein Vaccines and Adjuvants — BIOLOGICAL
  Sodium Chloride for Injection, USP 0.9%.

Study Details

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.

Key Dates

Start date

Sep 1, 2026

Status verified

Jun 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2029

Study Design

Enrollment

126 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1 (Treatment): Protein Vaccines/Alhydrogel
  Participants will receive 400 mcg Recombinant Protein Vaccines admixed with 800 mcg Alhydrogel adjuvant to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 0 and 3.
• Placebo Comparator: Group 1 (Control)
  Participants will receive Placebo to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Experimental: Group 2 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel boost
  Participants will receive 2000 mcg Plasmid DNA Vaccines to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0 and 1; and 400 mcg Recombinant Protein Vaccines admixed with 800 mcg Alhydrogel, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Placebo Comparator: Group 2 (Control)
  Participants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0 and 1; And Placebo to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Experimental: Group 3 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE
  Participants will receive 2000 mcg Plasmid DNA Vaccine to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0, and 1; and 400 mcg Recombinant Protein Vaccines admixed with 5 mcg GLA-SE, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Placebo Comparator: Group 3 (Control)
  Participants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0, and 1; and Placebo to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Experimental: Group 4 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel + DNA Vaccines boost
  Participants will receive 2000 mcg Plasmid DNA Vaccines to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0, 1, 3, and 6; and 400 mcg Recombinant Protein Vaccines admixed with 800 mcg Alhydrogel, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Placebo Comparator: Group 4 (Control)
  Participants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0, 1, 3, and 6; and Placebo for to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Experimental: Group 5 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE + DNA vaccines boost
  Participants will receive 2000 mcg Plasmids DNA Vaccines to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0, 1, 3, and 6; and 400 mcg Recombinant Protein Vaccines admixed with 5 mcg GLA-SE, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
• Placebo Comparator: Group 5 (Control)
  Participants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0, 1, 3, and 6; and Placebo to be administered as a 0.9 mL (IM) injection into the deltoid of the NON-DOMINANT arm at months 3 and 6.

Primary Outcome Measure

Frequency of local injection site (including DTH) reactogenicity signs and symptoms [ Time Frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in ]

Central Contacts

• Project manager
  508-282-9447
  [email protected]

Locations (1)

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