Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults - Trial NCT06205056
Access comprehensive clinical trial information for NCT06205056 through Pure Global AI's free database. This Phase 1 trial is sponsored by U.S. Army Medical Research and Development Command and is currently Not yet recruiting. The study focuses on Human Immunodeficiency Virus. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
U.S. Army Medical Research and Development Command
Timeline & Enrollment
Phase 1
Jan 01, 2024
Sep 01, 2025
Primary Outcome
Occurrence and severity of solicited local and systemic adverse events (AEs) following candidate vaccine administration,Occurrence, severity, and relationship to vaccination of unsolicited adverse events after candidate vaccine administration,Occurrence of serious adverse events (SAEs) following candidate vaccine administration,Occurrence of adverse events of special interest (AESIs) following candidate vaccine administration
Summary
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
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06205056
Non-Device Trial