NCT06919016

A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA (Prime) Followed by DV701B1.1-RNA (Boost) in Adult Participants Without HIV

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• 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, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
BIOLOGICAL	DV700P-RNA	Intramuscular (IM) injection
BIOLOGICAL	DV701B1.1-RNA	IM injection

Timeline

• Start date: 2025-08-06
• Primary completion: 2027-03-25
• Completion: 2027-03-25
• First posted: 2025-04-09
• Last updated: 2025-12-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study