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

NCT03560258 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-04-26

Study results available
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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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jeffrey M. Jacobson, MD · School of Medicine at Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2021-02-10
Completion
2021-02-10
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560258 on ClinicalTrials.gov