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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001053
The ClinicalTrials.gov registry entry for NCT00001053 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 2 interventions - of which Aluminum hydroxide is the first listed.
NCT00001053 reports 0 study locations.
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.
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