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

Part of paid clinical trials in San Diego, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06071767
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ChAdOx1.tHIVconsv1 — BIOLOGICAL
    Administered as 0.4 mL intramuscularly (IM) at Week 0
  • ChAdOx1.HIVconsv62 — BIOLOGICAL
    Administered as 0.3 mL IM at Week 0
  • MVA.tHIVconsv3 — BIOLOGICAL
    Administered as 0.3 mL IM at Week 4
  • MVA.tHIVconsv4 — BIOLOGICAL
    Administered as 0.5 mL IM at week 4
  • Vesatolimod (VES) — DRUG
    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 — DRUG
    Administered via intravenous (IV) infusion at week 7
  • GS-2872 — DRUG
    Administered via IV infusion at week 7
  • MVA.tHIVconsv4 — BIOLOGICAL
    Administered 0.5 mL IM at week 60
  • Placebo — BIOLOGICAL
    Placebos for vaccines, VES, and bnAbs

Study Details

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).

Key Dates

Start date
Apr 1, 2024
Status verified
Jun 2026
Primary completion
Apr 29, 2028
Completion
Aug 1, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Active ChAdOx1 and MVA/HIVconsvX vaccines, vesatolimod and bnAbs
  • Placebo Comparator: Arm B: Placebos for vaccines, vesatolimod and bnAbs

Primary Outcome Measure

Occurrence of any serious adverse event (AE), Grade 3 or higher AE, or AE that leads to permanent discontinuation of study treatment regardless of grade, that is related to ChAdOx1-MVA/HIVconsvX vaccines, vesatolimod, GS-5423 or GS-2872 [ Time Frame: Week 0 to Week 64 ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, San Diego AntiViral Research Center CRSSan DiegoCalifornia92103
Steven Hendrickx, BSN
[email protected]
619-543-6968
Ponce de Leon Center CRSAtlantaGeorgia30308
Ericka Patrick, RN, MSN
[email protected]
404-616-6313
Northwestern University CRSChicagoIllinois60611
Sherryl Wolfe, BSN, RN
[email protected]
312-695-4997
Massachusetts General Hospital CRS (MGH CRS)BostonMassachusetts02114
Amy Sbrolla, ACRN, BSN
[email protected]
617-726-5598
Washington University Therapeutics CRSSt LouisMissouri63110
Michael Klebert, RN, NP-C, PhD
[email protected]
314-747-1098
Columbia Physicians & Surgeons CRSNew YorkNew York10032
Mascha Elskamp
[email protected]
212-305-2201
Chapel Hill CRSChapel HillNorth Carolina27599
Erin Hoffman, BS
[email protected]
919-843-0720
Ohio State University CRSColumbusOhio43210
Lindsay Summers, MPH
[email protected]
614-293-8529
Penn Therapeutics CRSPhiladelphiaPennsylvania19104
Jamie Doyle
[email protected]
215-615-2316
Houston AIDS Research Team CRSHoustonTexas77004
Maria Martinez, BS
[email protected]
713-500-6718

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By research site
University of California, San Diego AntiViral Research Center CRS· San Diego, CAPonce de Leon Center CRS· Atlanta, GANorthwestern University CRS· Chicago, ILMassachusetts General Hospital CRS (MGH CRS)· Boston, MAWashington University Therapeutics CRS· St Louis, MOColumbia Physicians & Surgeons CRS· New York, NY

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