CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
p24CE1/2 pDNA vaccine +3 morebiological
Likely dose
p24CE1/2 pDNA vaccine 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03560258
NCT03560258Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 18, 2018·Updated Apr 26, 2022

In Brief

A Phase 2 clinical trial evaluating p24CE1/2 pDNA vaccine, p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine, and 2 other interventions for HIV Infections. Completed, enrolled 45 participants across 15 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 18, 2018
Enrollment StartMar 26, 2019
Primary CompletionFeb 10, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.0 years ago

Interventions

p24CE1/2 pDNA vaccinebiological

4 mg administered by one injection/electroporation

p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccinebiological

2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation

Full-length p55^gag pDNA vaccinebiological

4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation

Placebobiological

1 mL placebo administered by one injection/electroporation