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

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.

NCT Number	NCT06919016
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID) Collaborators: National Institutes of Health (NIH), Department of Health and Human Services
Conditions	HIV-1-infection
Enrollment	45 participants
Start Date	2025-08-06
Primary Completion	2027-03-25 (estimated)
Study Completion	2027-03-25 (estimated)
Updated on ClinicalTrials.gov	2025-12-16