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

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	DV201P-RNA	To be administered intramuscularly as a split dose.
BIOLOGICAL	DV202B1-RNA	To be administered intramuscularly as a split dose.

Timeline

• Start date: 2026-03-25
• Primary completion: 2027-12-14
• Completion: 2027-12-14
• First posted: 2026-02-05
• Last updated: 2026-04-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study