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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date pushed from Oct 1, 2026 to Oct 19, 2026 · Site details revised at 8 of 8 sites Show 2 more changesShow less
    • Start date pushed from Oct 1, 2026 to Oct 19, 2026
    • Site details revised at 8 of 8 sites
  2. Primary endpoints: details revised at 1 of 10 entries Start date: Sep 10, 2026 to Oct 1, 2026 · Eligibility criteria expanded, about 28 words · Site details revised at 8 of 8 sites Show 3 more changesShow less
    • Start date: Sep 10, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 28 words
    • Site details revised at 8 of 8 sites
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07757802
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions HIV
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov