Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults — RV591  

Human Immunodeficiency Virus Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

This study is exploratory and will be a randomized, placebo-controlled, double-blind trial. A total of 50 healthy male and female participants, aged 18 to 50 years, who are at low risk for Human Immunodeficiency Virus (HIV) acquisition will be enrolled and randomized across two Arms with 25 individuals per Arm. In each Arm, participants will be randomized 4:1 to active study vaccine versus placebo (normal saline) and followed for up to 18 months. All products will be administered by intramuscular (IM) injection into the same quadriceps muscle at each product administration visit.

Participants randomized to receive active study vaccines in Arm 1 will receive dose-consistent injections of Ad26.Mos4.HIV (5x10^10 viral particles [vp]/0.5 mL) and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) co-administered on Study Days 1, 57, and 169.

Participants randomized to receive active study vaccines in Arm 2 will receive a lower dose of Ad26.Mos4.HIV (2.5x10^10 vp/0.25 mL) and CH505 TF chTrimer (30 µg)+ALFQ (50 µg MPLA/25 µg QS-21) on Study Day 1, followed by rapid dose-escalating injections of CH505 TF chTrimer (100 µg, 150 µg, and 300 µg)+ALFQ (50 µg MPLA/25 µg QS-21) over a 14-day period, then injections of Ad26.Mos4.HIV (5x10^10 vp/0.5 mL) and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) on Study Days 57 and 169.

Enrollment into Arms 1 and 2 will be concurrent. Sentinel groups, comprised of the first four participants enrolled in each Arm (3:1 active vaccine to placebo), will be included to facilitate an assessment of the safety of the combination of products and vaccination regimens. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

• NCT number: NCT06205056
• Study type: Interventional
• Source: U.S. Army Medical Research and Development Command
• Contact: Grace Mirembe, MBChB, MMed
• Phone: +256 312 330400
• Email: gmirembe@muwrp.org
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2024
• Completion date: September 2025