Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT03560258
Brief Summary:
This study evaluated the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who were on antiretroviral therapy (ART). The study aimed to induce potent virus-specific cytotoxic T lymphocytes (CTL) responses.
Detailed Description:
This study evaluated the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who were on antiretroviral therapy (ART).
The study randomly assigned participants to one of three groups. Participants in Arm 1 received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24. Participants in Arm 2 received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24. Participants in Arm 3 received placebo at Weeks 0, 4, 12, and 24.
Study visits occurred at Weeks 0, 4, 6, 12, 24, 26, and 48 and included physical examinations and blood and urine collection. Some participants underwent leukapheresis and stool sample collection.
Study:
NCT03560258
Study Brief:
Protocol Section:
NCT03560258