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 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。确定在 0 个月和 6 个月时给予的重组乙型肝炎疫苗（Recombivax HB：10 mcg HBsAg：默克疫苗部门，西点，宾夕法尼亚州）的免疫原性以及甲型和乙型肝炎联合疫苗（Twinrix：葛兰素史克制药公司 20 mcg HbsAg 和720 EL.U Hep. A 抗原/1.0ml) HIV 阴性青少年年龄 12-17 岁。确定这 2 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、坦纳分期、体重指数 (BMI)、吸烟和吸毒。确定两种疫苗产品在 18 个月的随访期内保护性抗体滴度的持续性。确定联合疫苗组 (Twinrix) 受试者在两个时间点的甲型肝炎抗体反应：第二次疫苗接种后 1 个月和 12 个月。评估仅接受一次疫苗接种的人和在指定时间窗口之外接受第二次疫苗接种的人的抗体反应对 HepB 功效主要终点的影响。确定受试者对简化疫苗同意书/同意书的理解。确定参与疫苗试验对高风险行为（性活动和其他活动）的影响。