ATN 025 Physical Exam Form: Skin [CRF 7] Dataset in Hepatitis B Vaccination in Youth at Adolescent Trials Network Sites: Effectiveness of Two Strategies and Evaluation of Tools to be Used in Future HIV Prevention Trials

Data from Physical Exam Form: Skin [CRF 7]
Study Description
A randomized, single-blinded trial evaluating two licensed vaccine products, Recombivax and Twinrix, given in a two-dose schedule to youth at risk for HIV and hepatitis B infection. Primary objectives were to determine immunogenicity of the products in the study population and to determine safety and tolerability of the vaccines given in the two regimens.
HIV and hepatitis B negative youth aged 12 to 17

来自体格检查表单：皮肤部分[病例报告表7（CRF 7）]
研究概况
本研究为一项随机单盲临床试验，旨在评估两种已获批疫苗产品——重组酵母乙型肝炎疫苗（Recombivax）与甲肝乙肝联合疫苗（Twinrix）——以两剂次接种方案应用于HIV及乙型肝炎病毒感染高风险青少年的效果。本研究的主要研究目标为：明确两款疫苗在本次研究人群中的免疫原性，以及两种接种方案下疫苗的安全性与耐受性。研究对象为12至17岁、HIV及乙型肝炎病毒血清学检测均为阴性的青少年。