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RECRUITING
NCT06071767
PHASE1/PHASE2

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)

View on ClinicalTrials.gov

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

BIOLOGICAL

ChAdOx1.tHIVconsv1

Administered as 0.4 mL intramuscularly (IM) at Week 0

BIOLOGICAL

ChAdOx1.HIVconsv62

Administered as 0.3 mL IM at Week 0

BIOLOGICAL

MVA.tHIVconsv3

Administered as 0.3 mL IM at Week 4

BIOLOGICAL

MVA.tHIVconsv4

Administered as 0.5 mL IM at week 4

DRUG

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.

DRUG

GS-5423

Administered via intravenous (IV) infusion at week 7

DRUG

GS-2872

Administered via IV infusion at week 7

BIOLOGICAL

MVA.tHIVconsv4

Administered 0.5 mL IM at week 60

BIOLOGICAL

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