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Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).
Official title: A Phase I/IIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen With Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy During Acute HIV-1
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2024-04-01
Completion Date
2029-08-01
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
ChAdOx1.tHIVconsv1
Administered as 0.4 mL intramuscularly (IM) at Week 0
ChAdOx1.HIVconsv62
Administered as 0.3 mL IM at Week 0
MVA.tHIVconsv3
Administered as 0.3 mL IM at Week 4
MVA.tHIVconsv4
Administered as 0.5 mL IM at week 4
Vesatolimod (VES)
VES 6 mg administered orally once every 2 weeks for two doses, then VES 8 mg once every 2 weeks for 8 doses. Dose escalation may be held or the 8 mg dose may be reduced for intolerability for weeks 6 through 24.
GS-5423
Administered via intravenous (IV) infusion at week 7
GS-2872
Administered via IV infusion at week 7
MVA.tHIVconsv4
Administered 0.5 mL IM at week 60
Placebo
Placebos for vaccines, VES, and bnAbs
Locations (12)
University of California, San Diego AntiViral Research Center CRS
San Diego, California, United States
Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States
Washington University Therapeutics CRS
St Louis, Missouri, United States
Columbia Physicians & Surgeons CRS
New York, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Ohio State University CRS
Columbus, Ohio, United States
Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States
Houston AIDS Research Team CRS
Houston, Texas, United States
Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil