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NCT00865566 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 2,504
- Enrollment target
NCT00865566: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00865566 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2,504 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1783% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00865566, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2,504 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men. NOTES: As of April 2013, all vaccinations in this study have been stopped. As of June 2017, this study has been closed.
Primary Outcome
For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
Interventions
- BIOLOGICAL DNA plasmid vaccine
- BIOLOGICAL Recombinant adenoviral serotype 5 (rAD5) vector vaccine
- BIOLOGICAL DNA vaccine placebo
- BIOLOGICAL HIV-1 recombinant adenovirus vaccine placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,504 participants |
| Start Date | 2009-05 |
| Est. Completion | 2017-10-06 |
| Phase | Phase 2 |
Why NCT00865566 stopped before completion
NCT00865566 is an interventional study that assigns participants to a tested intervention. Its 2,504 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1783% higher).
The record links to 0 conditions, and to 4 interventions - of which DNA plasmid vaccine is the first listed.
NCT00865566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00865566 about?
NCT00865566 is a clinical study titled "Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men". The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men. NOTES: As of April 2013, all vaccinations in this study have been stopped. As of June 2017, this stud...
What is the current status of trial NCT00865566?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2,504 participants. The study started on 2009-05. Estimated completion is 2017-10-06.
What interventions are being tested in trial NCT00865566?
The interventions under investigation include: DNA plasmid vaccine (BIOLOGICAL), Recombinant adenoviral serotype 5 (rAD5) vector vaccine (BIOLOGICAL), DNA vaccine placebo (BIOLOGICAL), HIV-1 recombinant adenovirus vaccine placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT00865566?
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 NCT00865566's enrollment target sits among peer trials
2,504 8th of 2000 higher than 1,993 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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