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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 is a Phase 3 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 1,260 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00841477
The ClinicalTrials.gov registry entry for NCT00841477 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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