drugset / Trial / NCT07757802
Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |