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) · collab National Institute of Mental Health (NIMH) · collab National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab National 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

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Recombivax vs Twinrix; p = 0.2954; Fisher Exact NCT00107042 ↗

Publications

Cunningham CK, Rudy BJ, Xu J, Bethel J, Kapogiannis BG, Ahmad S, Wilson CM, Flynn PM; Adolescent Medicine Trials Network for HIV/AIDS Interventions. Randomized trial to determine safety and immunogenicity of two strategies for hepatitis B vaccination in healthy urban adolescents in the United States. Pediatr Infect Dis J. 2010 Jun;29(6):530-4. doi: 10.1097/INF.0b013e3181d285c7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Recombivax	Vaccine	10 ug	—
Subject	Twinrix	Vaccine	20 ug	—