Pure Global
NCT06205056

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

Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults
U.S. Army Medical Research and Development Command·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Human Immunodeficiency Virus
Drug/Device/Intervention
Ad26.Mos4.HIV [Arm 1]
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
U.S. Army Medical Research and Development Command
Location
Kampala, Uganda
Timeline & enrollment
Phase
Phase 1
Start date
Jan 01, 2024
End date
Sep 01, 2025
Enrollment
50 participants
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
Human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesAsymptomatic human immunodeficiency virus [HIV] infection status
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06205056
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.