Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults

This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV

NCT Number	NCT06205056
Lead Sponsor	U.S. Army Medical Research and Development Command Collaborators: Janssen Vaccines & Prevention B.V., Henry M. Jackson Foundation for the Advancement of Military Medicine, Duke University, Walter Reed Army Institute of Research (WRAIR), National Institute of Allergy and Infectious Diseases (NIAID), Makerere University Walter Reed Project
Conditions	Human Immunodeficiency Virus
Enrollment	78 participants
Start Date	2024-01-30
Primary Completion	2025-12 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-10-07