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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Stabilized CH505 TF chTrimer, 300 mcg
3 mcg
500 mcg
Sodium chloride for injection, 0.9% USP volume-matched placebo injection.
University of California, Los Angeles CARE Center CRS
Los Angeles, California, United States
UCSD Antiviral Research Center CRS
San Diego, California, United States
University of California, San Francisco HIV/AIDS CRS
San Francisco, California, United States
Harbor University of California Los Angeles Center CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
...and 14 more locations
Proportion of participants who initiated active study treatment (CH505 TF chTrimer, 3M-052-AF and Alum) who met the study-defined primary safety composite endpoint
The study-defined primary safety endpoint is a composite endpoint. A participant who has initiated active study treatment is considered to have met the endpoint if the participant has experienced any treatment-related (i.e., related to CH505 TF chTrimer, 3M-052-AF or Alum as judged by the core team, blinded to study treatment) 1) serious adverse event (SAE), or 2) Grade 3+ adverse event (AE), or 3) AE that led to permanent discontinuation of study treatment regardless of grade
Time frame: Day 0 (after initial vaccination) to 4 weeks (28 days) after the last vaccination
Number of the viruses with antibody neutralization response for a cross-clade global panel of 9 viruses expressing heterologous envelopes determined using a neutralization assay
Time frame: Day 0 pre-vaccination to 2 weeks (14 days) after the fifth vaccination
Antibody neutralization response for vaccine-matched and related viruses
Determined using a neutralization assay and CH505 TF and related vaccine matched virus panel
Time frame: Day 0 pre-vaccination to 2 weeks (14 days) after the fifth vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.