drugset / Trial / NCT06680479
Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy
Phase 1
Suspended
30 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Access to Advanced Health Institute (AAHI) · collabDuke University · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2025-04-01
- Primary completion
- 2027-04-30
- Completion
- 2028-04-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CH505 TF chTrimer | Vaccine | 300 ug | — |
| Background | 3M-052-AF | Small molecule | 3 ug | — |
| Background | Aluminum Hydroxide Suspension | Unknown | 500 ug | — |
Indications
No indication recorded.