A5369: HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) as Therapeutic Vaccination in HIV-Infected Persons with Viral Suppression on Antiretroviral Therapy

  • STATUS
    Recruiting
  • participants needed
    5
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Updated on 19 February 2024

Summary

A5369 is a phase I/IIa, randomized, double-blind, placebo-controlled study to evaluate the safety, immunogenicity, and efficacy of p24CE/full-length Gag DNA, as a therapeutic vaccine in HIV-1 infected persons. The study targets to enroll 40 participants. All participants are well-suppressed on ART, current CD4 T cell counts greater than 500 cells/mm3, and nadir CD4 T cell counts greater than 350 cells/mm3. Each participant will receive active vaccine/placebo at weeks 0, 4, 12, and 24 delivered by electroporation after intramuscular injection. The primary efficacy outcome will be based on HIV-specific immunologic assays at baseline and week 26.

Details
Condition ['HIV Infections']
Age 99years or below
Clinical Study Identifier03560258
Last Modified on19 February 2024

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