Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
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
National Institute of Allergy and Infectious Diseases (NIAID)
36 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Administered as 0.4 mL intramuscularly (IM) at Week 0
Administered as 0.3 mL IM at Week 0
Administered as 0.3 mL IM at Week 4
Administered as 0.5 mL IM at week 4
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.
Administered via intravenous (IV) infusion at week 7
Administered via IV infusion at week 7
Administered 0.5 mL IM at week 60
Placebos for vaccines, VES, and bnAbs
Locations(12)
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NCT06071767