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
About This Trial
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).
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
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