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

Study acronym: RV591
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 7, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 10 more changesShow less
    • Enrollment target: 50 to 78
    • Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Sep 2025 to Jun 2026
    • Start date changed from estimate of Jan 2024 to Jan 30, 2024
    • Interventions: ALFQ [Arm 1] (Biological), ALFQ [Arm 2] (Biological), Ad26.Mos4.HIV [Arm 1] (Biological), Ad26.Mos4.HIV [Arm 2] (Biological), CH505 TF… to Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a] (Biological), Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a] (Biological), CH505 TF…
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 4 to 2
    • Study description expanded, about 567 words
    • Site details revised
    • Study arms: 2 to 4
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
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
(from sponsor)		 Human Immunodeficiency Virus
Related terms Acquired Immunodeficiency Syndrome
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov