RECRUITING

Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1

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Conditions

HIV-1-infectionSuppressive Antiretroviral TherapyHIVAcute HIV-1HIV vaccineT-cell vaccineTherapeutic T-cell vaccineChAdOx1MVAConserved region vaccineHIVconsvXToll-like receptor 7 agonistTLR7Broadly neutralizing antibodyAntibodiesHIV antibodyHIV Broadly neutralizing antibody

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-04-01
Study Completion:2029-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06071767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Sharon Riddler, MD, MPH
STUDY_CHAIR
University of Pittsburgh

Study Locations (Sites)

University of California, San Diego AntiViral Research Center CRS
San Diego, California, 92103
United States
Ponce de Leon Center CRS
Atlanta, Georgia, 30308
United States
Northwestern University CRS
Chicago, Illinois, 60611
United States
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, 02114
United States
Washington University Therapeutics CRS
Saint Louis, Missouri, 63110
United States
Columbia Physicians & Surgeons CRS
New York, New York, 10032
United States
Chapel Hill CRS
Chapel Hill, North Carolina, 27599
United States
Greensboro CRS
Greensboro, North Carolina, 27401
United States
Cincinnati CRS
Cincinnati, Ohio, 45267
United States
Ohio State University CRS
Columbus, Ohio, 43210
United States
Penn Therapeutics CRS
Philadelphia, Pennsylvania, 19104
United States
Houston AIDS Research Team CRS
Houston, Texas, 77004
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Sharon Riddler, MD, MPH, STUDY_CHAIR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2029-08-01

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2029-08-01

Terms related to this study

Keywords Provided by Researchers

  • Suppressive Antiretroviral Therapy
  • HIV
  • Acute HIV-1
  • HIV vaccine
  • T-cell vaccine
  • Therapeutic T-cell vaccine
  • ChAdOx1
  • MVA
  • Conserved region vaccine
  • HIVconsvX
  • Toll-like receptor 7 agonist
  • TLR7
  • Broadly neutralizing antibody
  • Antibodies
  • HIV antibody
  • HIV Broadly neutralizing antibody

Additional Relevant MeSH Terms

  • HIV-1-infection