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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。检测重组乙肝疫苗(Recombivax HB：10 MCG-HBs：Merck疫苗事业部，西点军校，PA)在0个月和6个月时的免疫原性以及甲型和乙型肝炎联合疫苗(Twinrix：GlaxoSmithKline PharmPharmticals：GlaxoSmithKline PharmPharmticals 20mcg-HBs和720EL.U-Hep)的免疫原性。A抗原/1.0ml)在12-17岁HIV阴性青年中。确定这两种方案所接种疫苗的安全性和可接种性。探讨可能与疫苗反应不足有关的因素，包括性别、种族、年龄、晒黑阶段、身体质量指数(BMI)、吸烟和药物使用。以确定两种疫苗产品的保护性抗体效价在18个月的随访期内的持久性。在两个时间点：第二次接种后1个月和12个月，测定联合疫苗组(Twinrix)受试者的甲型肝炎抗体应答。评估只接种一次疫苗的人和第二次接种不在指定时间窗口的人的抗体应答对乙肝病毒疗效的主要终点的影响。确定受试者对简化疫苗同意/同意书的理解。以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).