NCT06680479

Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A5422 is a phase 1, randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, and immunogenicity of a vaccination with stabilized CH505 TF chTrimer admixed with 3M-052-AF + Aluminum hydroxide (Alum), to assess the effect of CH505 TF chTrimer vaccine as a therapeutic vaccine in adults living with HIV-1 on suppressive antiretroviral therapy (ART) with the aim of inducing new HIV-1 Envelope (Env) B-cell neutralizing immune responses. Participants will be on study for up to 100 weeks (52 weeks on study treatment plus 48 weeks follow-up).

Conditions

• HIV-1

Interventions

Type	Name	Description
BIOLOGICAL	CH505 TF chTrimer	Stabilized CH505 TF chTrimer, 300 mcg
BIOLOGICAL	3M-052-AF	3 mcg
BIOLOGICAL	Aluminum Hydroxide Suspension	500 mcg
OTHER	Sodium Chloride for Injection	Sodium chloride for injection, 0.9% USP volume-matched placebo injection.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-30
• Completion: 2028-04-14
• First posted: 2024-11-08
• Last updated: 2026-03-03

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study