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

ATN 站点的青少年乙型肝炎疫苗接种：两种策略的有效性

• 批准号: 7376312
• 负责人: Sue Ellen Abdalian
• 金额: $ 1.13万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376312
• 关键词: HEPATITIS; VACCINATION; YOUTH; ATN; SITES

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).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。 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)在艾滋病毒负面青年12-17岁。确定这两种方案中给出的疫苗的安全性和耐受性。探索可能与对疫苗的反应不足有关的因素，包括性别，种族，年龄，坦纳阶段，体重指数（BMI），吸烟和吸毒。确定两种疫苗产品的18个月随访期间保护性抗体滴度的持久性。确定在两个时间点合并疫苗组（Twinrix）中这些受试者中的肝炎A抗体反应：第二次疫苗接种后1和12个月。为了评估仅接种单个疫苗接种的人和第二次疫苗接种的人对HEPB疗效的主要终点的影响。确定对简化疫苗同意/同意形式的主题理解。确定参与疫苗试验对高风险行为（性和其他活动）的影响。