RecruitingPhase 1Phase 2NCT06071767

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


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

36 participants

Start Date

Apr 1, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug immune-based treatment strategy for people who started HIV treatment very early (within 90 days of being diagnosed with acute HIV infection). Researchers want to see whether this combination can train the immune system to better control HIV, with the goal of one day allowing people to reduce or pause treatment. **You may be eligible if...** - You started HIV antiretroviral therapy (ART) within 90 days of being diagnosed with early HIV - You have been on ART continuously for at least 12 months - Your current ART includes an integrase inhibitor - You are willing to participate in a monitored treatment interruption - Your viral load is undetectable and immune cell counts are healthy **You may NOT be eligible if...** - You have serious chronic illness other than HIV - You have a history of certain cancers or serious immune conditions - You are pregnant or breastfeeding - You have missed more than 28 consecutive days of ART in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALChAdOx1.tHIVconsv1

Administered as 0.4 mL intramuscularly (IM) at Week 0

BIOLOGICALChAdOx1.HIVconsv62

Administered as 0.3 mL IM at Week 0

BIOLOGICALMVA.tHIVconsv3

Administered as 0.3 mL IM at Week 4

BIOLOGICALMVA.tHIVconsv4

Administered as 0.5 mL IM at week 4

DRUGVesatolimod (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.

DRUGGS-5423

Administered via intravenous (IV) infusion at week 7

DRUGGS-2872

Administered via IV infusion at week 7

BIOLOGICALMVA.tHIVconsv4

Administered 0.5 mL IM at week 60

BIOLOGICALPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06071767


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