drugset / Trial / NCT07757802

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

NCT07757802 ↗

NaSequentialOpen-labelPrevention

Summary

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.

Timeline

Start
2026-10-19
Primary completion
2028-06-07
Completion
2028-10-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ACU-026-001-1 Unknown 1 mg Intramuscular
Subject ACU-026-001-1 Unknown 2 mg Intramuscular
Subject CH505 TF mRNA-gp160 Messenger RNA (mRNA) 100 ug Intramuscular
Subject CH505 w24 mRNA-gp160 Messenger RNA (mRNA) 100 ug Intramuscular
Subject DV901-NP Vaccine 100 ug Intramuscular
Subject DV901-NP Vaccine 150 ug Intramuscular
Subject DV901-NP Vaccine 300 ug Intramuscular
Subject DV902-NP Vaccine 100 ug Intramuscular
Subject DV902-NP Vaccine 300 ug Intramuscular