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NCT00841477 · ClinicalTrials.gov registry record · Phase 3
An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users
A Phase 3 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,260
- Enrollment target
NCT00841477: Completed Phase 3 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT00841477 is a Phase 3 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 1,260 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841477, a Phase 3 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,260 participants
- Enrollment target
Study Summary
The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine trial, examining the efficacy of community-based outreach intervention as well as an accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV vaccination protocols among not-in-treatment drug users. This study will also examine the effect of HBV vaccination coupled with community-based outreach intervention on reducing the incidence of HIV, HBV and HCV infections and the frequency of needle use and sexual risk behaviors related to these viral transmissions. A secondary purpose will be to assess the antibody response after HBV vaccination as a measurement of immunological response in drug users.
Interventions
- BIOLOGICAL hepatitis B vaccine 3 dose schedule (0,1,2 month)
- BEHAVIORAL HBV Vaccination Self-Efficacy Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,260 participants |
| Start Date | 2004-01 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00841477 record still lists
NCT00841477 is an interventional study that assigns participants to a tested intervention. Its 1,260 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which hepatitis B vaccine 3 dose schedule (0,1,2 month) is the first listed.
NCT00841477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00841477 about?
NCT00841477 is a clinical study titled "An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users". The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine trial, examining the efficacy of community-based outreach intervention as well as an accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV vaccination protocols among not-in-t...
What is the current status of trial NCT00841477?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,260 participants. The study started on 2004-01. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00841477?
The interventions under investigation include: hepatitis B vaccine 3 dose schedule (0,1,2 month) (BIOLOGICAL), HBV Vaccination Self-Efficacy Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00841477?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00841477's enrollment target sits among peer trials
1,260 204th of 2000 higher than 1,796 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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