drugset / Trial / NCT00107042
Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
Phase 2
Completed
123 enrolled
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Mental Health (NIMH) · collabNational Institute on Alcohol Abuse and Alcoholism (NIAAA) · collabNational Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupSingle-blindPrevention
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).
Timeline
- Start
- 2004-02
- Primary completion
- 2008-07
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hepatitis B vaccine | Vaccine | 10 ug | — |
| Subject | Twinrix | Vaccine | 20 ug | — |