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NCT00107042 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT00107042: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT00107042 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00107042, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).
Primary Outcome
Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows: Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL.
Interventions
- BIOLOGICAL Twinrix
- BIOLOGICAL Recombivax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2004-02 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
What the finished NCT00107042 record still lists
NCT00107042 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Twinrix is the first listed.
NCT00107042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00107042 about?
NCT00107042 is a clinical study titled "Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths". This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune res...
What is the current status of trial NCT00107042?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2004-02. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00107042?
The interventions under investigation include: Twinrix (BIOLOGICAL), Recombivax (BIOLOGICAL).
Who is sponsoring clinical trial NCT00107042?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00107042's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 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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