This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. To determine immunogenicity of a recombinant Hepatitis B vaccine (Recombivax HB: 10 mcg HBsAg: Merck Vaccine Division, West Point, PA) given at 0 and 6 months AND immunogenicity of a combined Hepatits A and B vaccine (Twinrix: GlaxoSmithKline Pharmaceuticals 20mcg HbsAg and 720 EL.U Hep. A antigen/1.0ml) in HIV negative youth age 12-17 years. To determine safety and toloerability of the vaccines given in these 2 regimens. To explore factors potentially associated with inadequate response to vaccine including gender, race, age, Tanner stage, Body Mass Index (BMI), cigarette smoking and drug use. To determine persistence of protective antibody titers over an 18 month follow-up period for both vaccine products. To determine Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after 2nd vaccination. To assess the impact on the primary endpoint of HepB efficacy of the antibody responses in those who received only a single vaccination and in those whose second vaccination was outside of the specified time window. To determine subject understanding of a simplified vaccine assent/consent form. To determine the impact of participation in a vaccine trial on high-risk behavior (sexual and other activity).
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