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
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).
• Provision of written informed consent.
• History of Initiation of combination ART within 90 days of acute HIV diagnosis
• No known ART interruption \>14 consecutive days since initiation of ART.
• ART with an integrase inhibitor-based regimen with two NRTIs or dolutegravir/lamivudine regimen for at least 6 weeks prior to study entry.
• Willingness to participate in the ATI and willingness to restart ART according to study guidelines.
• Willingness to adhere to protocol therapy and complete all study visits.
• Weight ≥50 kg and ≤150 kg at Screening.
• CD4 cell count ≥500 cells/mm3 obtained within 60 days prior to study Entry.
• HIV-1 RNA \<50 copies/mL (or below the assay limit of quantification if local assay lower limit of quantification is \>50 copies/mL) since initial viral suppression on ART and for at least 1 year and within 60 days prior to study Entry.
• Select laboratory results within 60 days of study entry
• For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 48 hours prior to or at study Entry.
• Participants who are able to become pregnant and who are engaging in sexual activity that could lead to pregnancy must agree to use two methods of contraception, one of which must be a highly effective methods for contraception. Barrier methods of contraception are required for the second method of contraception.
• Availability of results of HLA typing (required for randomization).
• Completion of pre-entry leukapheresis or LVBD.