HEPATITIS B VACCINATION IN YOUTH AT ATN SITES: EFFECTIVENESS OF TWO STRATEGIES

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。测定在0个月和6个月接种的重组乙肝疫苗（Recombivax HB: 10 mcg HBsAg：默克疫苗部门，西点，宾夕法尼亚州）的免疫原性，以及甲乙肝联合疫苗（Twinrix：葛兰素史克制药公司20mcg HBsAg和720 EL）的免疫原性。你消息灵通的。12-17岁HIV阴性青年中1抗原/1.0ml)。确定这两种方案中疫苗的安全性和耐受性。探讨可能与疫苗反应不足相关的因素，包括性别、种族、年龄、Tanner分期、体重指数（BMI）、吸烟和吸毒。确定两种疫苗产品在18个月随访期间保护性抗体滴度的持久性。在两个时间点：第二次接种后1个月和12个月，确定联合疫苗组（Twinrix）受试者的甲型肝炎抗体反应。评估仅接受一次疫苗接种和在指定时间窗之外进行第二次疫苗接种的人的抗体应答对HepB疗效的主要终点的影响。确定受试者对简化疫苗同意/同意表的理解程度。确定参与疫苗试验对高危行为（性行为和其他活动）的影响。

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).