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NCT03560258 · ClinicalTrials.gov registry record · Phase 1
HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03560258 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 45 participants.
The verdict
NCT03560258, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL p24CE1/2 pDNA vaccine
- BIOLOGICAL p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine
- BIOLOGICAL Full-length p55^gag pDNA vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2021-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03560258
The ClinicalTrials.gov registry entry for NCT03560258 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03560258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03560258 about?
NCT03560258 is a clinical study titled "HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study". 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 po...
What is the current status of trial NCT03560258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2019-03-26. Estimated completion is 2021-02-10.
What interventions are being tested in trial NCT03560258?
The interventions under investigation include: Placebo (BIOLOGICAL), p24CE1/2 pDNA vaccine (BIOLOGICAL), p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine (BIOLOGICAL), Full-length p55^gag pDNA vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03560258?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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