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NCT00001053 · ClinicalTrials.gov registry record · Phase 1
A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00001053: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001053 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001053, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles) vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be cross-reactive against multiple HIV-1 stains. Also, to determine whether boosting with the vaccine orally or rectally will help induce mucosal antibody responses. Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine. Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1.
Interventions
- BIOLOGICAL Aluminum hydroxide
- BIOLOGICAL HIV p17/p24:Ty-VLP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Est. Completion | 1996-03 |
| Phase | Phase 1 |
What the finished NCT00001053 record still lists
NCT00001053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Aluminum hydroxide is the first listed.
NCT00001053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001053 about?
NCT00001053 is a clinical study titled "A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects". To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles) vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be cross-reactive against multiple HIV-1 sta...
What is the current status of trial NCT00001053?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. Estimated completion is 1996-03.
What interventions are being tested in trial NCT00001053?
The interventions under investigation include: Aluminum hydroxide (BIOLOGICAL), HIV p17/p24:Ty-VLP (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001053?
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 NCT00001053's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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