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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Conserved elements (CEs) are regions of the HIV-1 p24Gag protein that rarely mutate. Seven such regions were considered in this study. At week 0 and at week 26, the CD4 cells and CD8 cells were tested to see whether they responded to each of these gene sequences. The number of regions which caused a CD4 or a CD8 response was counted. Then the difference was calculated: the number of CEs causing a response at week 26 minus the number of CEs causing a response at week 0.
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 |
What the finished NCT03560258 record still lists
NCT03560258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03560258 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03560258's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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