drugset / Trial / NCT05903339
Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV
Phase 1
Active not recruiting
36 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Non-randomizedSingle-groupOpen-labelPrevention
Summary
This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP (V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin NP design.
Timeline
- Start
- 2023-08-29
- Primary completion
- 2026-12-18
- Completion
- 2026-12-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 3M-052-AF | Small molecule | 5 ug | — |
| Subject | ACU-026-001-1 | Unknown | 2 mg | — |
| Subject | Alum | Unknown | 500 ug | — |
| Subject | V3G CH848 Pr-NP1 | Unknown | 60 ug | — |
| Subject | V3G CH848 Pr-NP1 | Unknown | 100 ug | — |
| Background | V3G CH848 mRNA-Tr2 | Messenger RNA (mRNA) | 50 ug | — |