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NCT00076037 · ClinicalTrials.gov registry record · Phase 1
Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 7
- Study locations
NCT00076037: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00076037 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 96 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00076037, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 7
- Study locations
Study Summary
The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance the immune response when given at the same time as a vaccine. This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy. The study will also evaluate the vaccine when given with an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells. It does not contain HIV, and it cannot cause HIV infection.
Conditions Studied
Interventions
- DRUG GM-CSF
- BIOLOGICAL HIV CTL MEP administered with RC529-SE adjuvant
Study Locations (7)
Alabama
- Alabama Vaccine CRS - Birmingham
California
- San Francisco Vaccine and Prevention CRS - San Francisco
Maryland
- Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore - Baltimore
Missouri
- Saint Louis Univ. School of Medicine, HVTU - St Louis
New York
- Univ. of Rochester HVTN CRS - Rochester
Tennessee
- Vanderbilt Vaccine CRS - Nashville
Washington
- FHCRC/UW Vaccine CRS - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2004-04 |
| Est. Completion | 2006-06 |
| Phase | Phase 1 |
What the finished NCT00076037 record still lists
NCT00076037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which GM-CSF is the first listed.
NCT00076037 lists 7 locations in 7 states (Alabama, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT00076037 about?
NCT00076037 is a clinical study titled "Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP". The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance...
What is the current status of trial NCT00076037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2004-04. Estimated completion is 2006-06.
What conditions does trial NCT00076037 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00076037?
The interventions under investigation include: GM-CSF (DRUG), HIV CTL MEP administered with RC529-SE adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT00076037?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00076037 being conducted?
This trial has 7 study locations across Alabama, California, Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00076037's enrollment target sits among peer trials
96 279th of 542 higher than 262 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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