drugset / Trial / NCT07390474
Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV
Non-randomizedSequentialOpen-labelPrevention
Summary
This is a phase 1, multicenter, open-label, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of DV201P-RNA and DV202B1-RNA, immunogens designed to induce HIV-1 envelope (Env) V2 apex-specific broadly neutralizing antibodies (V2 apex bnAbs). Both vaccines consist of a modified mRNA encapsulated in lipid nanoparticles (LNP) that when translated in cells produces HIV-1 Env gp150 transmembrane trimers. The trial will enroll adult volunteers without HIV and in overall good health.
Timeline
- Start
- 2026-03-25
- Primary completion
- 2027-12-14
- Completion
- 2027-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DV201P-RNA | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | DV201P-RNA | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | DV201P-RNA | Messenger RNA (mRNA) | 150 ug | Intramuscular |
| Subject | DV202B1-RNA | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | DV202B1-RNA | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | DV202B1-RNA | Messenger RNA (mRNA) | 150 ug | Intramuscular |