This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Suboptimal response to HBV in HIV-infected adults and children has been well documented in the literature. Given the importance of preventing HBV co-infection in HIV-infected youth and the findings of poor response in HIV-infected adolescents and young adults receiving the recommended dose and schedule within the REACH cohort, the Pediatric AIDS Clinical Trials Group (PACTG) will undertake a randomized clinical trial of three hepatitis B vaccination schemas in an attempt to improve sero-response and thus, achieve protection from HBV. This is a prospective, stratified, block-randomized, three-arm, open-label clinical trial of three groups with the standard adult Engerix B dose as Arm 1, a 2X standard dose Engerix B as Arm 2 and a combined hepatitis A/hepatitis B vaccine (Twinrix ) as Arm 3. Subjects will be HIV-infected adolescents and young adults (acquisition by any route) from age 12 to < 25 years who are either hepatitis B vaccine nanve or have received no more than one hepatitis B vaccine in the past and have negative Hepatitis B surface antibody at baseline. Patients will be randomized to one of the above regimens. The randomization will be blocked and stratified, with block size equal to 6. Absolute CD4+ T-lymphocyte cell count (<500 and >500) and previous HBV vaccination will define the strata. The randomization will be restricted so that the percentage of subjects with CD4+ T cell count < 200 cells/ml will not exceed 15% of subjects on each arm. The primary outcome, percentage sero-response, will be compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) in an intent-to-treat analysis.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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Special Emphasis Panel (ZRR1-CR-9 (01))
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University of Colorado Denver
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