Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults

Conditions

• HIV

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• DV901-NP — BIOLOGICAL
  CH505 HIV-1 envelope protein nanoparticle vaccine administered intramuscularly at doses of 100 mcg, 150 mcg, or 300 mcg, depending on study group. Administered with ACU-026-001-1 adjuvant.
• DV902-NP — BIOLOGICAL
  CH505 HIV-1 envelope protein nanoparticle booster vaccine administered intramuscularly at doses of 100 mcg or 300 mcg with ACU-026-001-1 adjuvant.
• CH505 TF mRNA-gp160 — BIOLOGICAL
  CH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Weeks 16 and 24.
• CH505 w24 mRNA-gp160 — BIOLOGICAL
  CH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Week 32.
• ACU-026-001-1 — BIOLOGICAL
  Investigational lipid nanoparticle adjuvant administered in combination with DV901-NP or DV902-NP. Dose is 2 mg for Groups 1-3 and 1 mg for Groups 4-5.

Study Details

This Phase 1 study will evaluate the safety, tolerability, and immune responses of investigational CH505 HIV vaccine regimens in adults in overall good health without HIV. Participants will receive CH505 protein nanoparticle vaccines (DV901-NP) formulated with the investigational adjuvant ACU-026-001-1, followed by either CH505 protein nanoparticle (DV902-NP) or CH505 mRNA vaccine boosters. The study will assess the ability of these regimens to induce HIV-specific immune responses, including B-cell responses associated with the development of broadly neutralizing antibodies. An immunology cohort will also evaluate how the location of booster vaccination affects immune responses.

Key Dates

First listed

Aug 11, 2026

Start date

Sep 10, 2026

Status verified

Aug 2026

Primary completion

Jun 7, 2028

Completion

Oct 7, 2028

Study Design

Enrollment

54 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1: DV901-NP Low-Dose Prime/DV902-NP Low-Dose Boost
  Participants receive DV901-NP (100 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral intramuscular (IM) injection at Weeks 0 and 8, followed by DV902-NP (100 mcg) adjuvanted with ACU-026-001-1 (2 mg) at Weeks 16 and 24.
• Experimental: Group 2: DV901-NP High-Dose Prime/DV902-NP High-Dose Boost
  Participants receive DV901-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral IM injection at Weeks 0 and 8, followed by DV902-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) at Weeks 16 and 24.
• Experimental: Group 3: DV901-NP Prime/CH505 mRNA Boosts
  Participants receive DV901-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral IM injection at Weeks 0 and 8, followed by CH505 TF mRNA-gp160 (100 mcg) at Weeks 16 and 24 and CH505 w24 mRNA-gp160 (100 mcg) at Week 32.
• Experimental: Group 4: Ipsilateral Prime/Contralateral Boost Immunology Cohort
  Participants receive DV901-NP (150 mcg) adjuvanted with ACU-026-001-1 (1 mg) by IM injection at Weeks 0, 4, and 28. The Week 0 and Week 4 vaccinations are administered in the same deltoid (ipsilateral), and the Week 28 vaccination is administered in the opposite deltoid (contralateral).
• Experimental: Group 5: Ipsilateral Prime/Ipsilateral Boost Immunology Cohort
  Participants receive DV901-NP (150 mcg) adjuvanted with ACU-026-001-1 (1 mg) by IM injection at Weeks 0, 4, and 28, with all vaccinations administered in the same deltoid (ipsilateral).

Primary Outcome Measure

Incidence of solicited local reactogenicity [ Time Frame: Through 14 days after each study vaccination ]

Locations (8)

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