Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV

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.

NCT Number	NCT07390474
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Conditions	HIV
Enrollment	40 participants
Start Date	2026-03-25
Primary Completion	2027-12-14 (estimated)
Study Completion	2027-12-14 (estimated)
Updated on ClinicalTrials.gov	2026-08-06