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

NCT07390474 ↗

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

EvaluationDrugModalityDoseRoute
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