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NCT00027261 · ClinicalTrials.gov registry record · Phase 1
Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT00027261: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00027261 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 110 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00027261, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.
Interventions
- BIOLOGICAL ALVAC(2)120(B,MN)GNP (vCP1452)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Est. Completion | 2005-12 |
| Phase | Phase 1 |
What the finished NCT00027261 record still lists
NCT00027261 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 1 intervention - of which ALVAC(2)120(B,MN)GNP (vCP1452) is the first listed.
NCT00027261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00027261 about?
NCT00027261 is a clinical study titled "Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults". The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, o...
What is the current status of trial NCT00027261?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00027261?
The interventions under investigation include: ALVAC(2)120(B,MN)GNP (vCP1452) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00027261?
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 NCT00027261's enrollment target sits among peer trials
110 514th of 2000 higher than 1,479 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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