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ATN 064 Sexually Transmitted Infection Screening Dataset in Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women

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https://dash.nichd.nih.gov/dataset/16069
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Data from Sexually Transmitted Infection Screening Results Form: Type Collected [CRF 12, question 3] Study Description A Phase II, open-label, multi-center study that evaluated the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women. The vaccine was administered at the recommended dose and schedule (Day 0, Week 8, and Week 24) with safety assessments after each vaccination and reactive antibody measurements pre- and post-vaccination. Attitudes and behaviors were measured using self-administered questionnaires. HIV-infected young women between 16 and 23 years of age

来源于性传播感染筛查结果表:采集类型[病例报告表(CRF) 12,第3题] 研究概况 一项评估HPV-6、-11、-16、-18型疫苗在感染人类免疫缺陷病毒(HIV)青年女性中的免疫原性、安全性、耐受性及行为学影响的II期开放标签多中心临床试验。该疫苗按照推荐剂量与程序(第0天、第8周及第24周)进行接种,每次接种后均开展安全性评估,并在疫苗接种前后检测反应性抗体水平。研究对象的态度与行为通过自填式问卷进行采集。 研究纳入人群为16至23岁的HIV感染青年女性
创建时间:
2017-04-14
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