NCT03560258

HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	p24CE1/2 pDNA vaccine	4 mg administered by one injection/electroporation
BIOLOGICAL	p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine	2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
BIOLOGICAL	Full-length p55^gag pDNA vaccine	4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
BIOLOGICAL	Placebo	1 mL placebo administered by one injection/electroporation

Timeline

• Start date: 2019-03-26
• Primary completion: 2021-02-10
• Completion: 2021-02-10
• First posted: 2018-06-18
• Last updated: 2022-04-26
• Results posted: 2022-04-26

Locations

15 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study