At a glance
ClinicalIndex Comparison Record- ✓HIV-negative youth aged 12-17 years
- ✓Negative hepatitis B serology (no HBsAg, HBsAb, or HBcAb)
- ✓No prior or incomplete/unknown hepatitis B immunization status
- ✓Willing to participate in HIV risk-reduction counseling and behavior assessment
- ✕Serious illness requiring systemic medications (excluding asthma treatment)
- ✕Previous allergic reaction to vaccines or vaccine constituents (yeast, thimerosal, aluminum)
- ✕Pregnancy
- ✕Current immunomodulator therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hepatitis B Vaccination in Youth at Adolescent Trial Network Sites: Effectiveness of Two Strategies and Evaluation of Tools To be Used in Future HIV Prevention Trials.
In Brief
A Phase 2 clinical trial evaluating Recombivax and Twinrix for Hepatitis B. Completed, enrolled 123 participants across 11 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
Participants receive doses of Recombivax at weeks 0 and 24.
Participants receive doses of Twinrix at weeks 0 and 24.