ATN 024: A RANDOMIZED, OPEN-LABEL TRIAL OF THREE HEPATITIS B VACCINATION

ATN 024：三种乙型肝炎疫苗的随机、开放标签试验

• 批准号: 7717172
• 负责人: LAWRENCE James D'ANGELO
• 金额: $ 2.82万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717172
• 关键词: Adolescent; Age-Years; CD4 Positive T Lymphocytes; Cell Count; Cells; Computer Retrieval of Information on Scientific Projects Database; Funding; Grant; Hepatitis; Hepatitis B Vaccination; Immune response; Institution; Label; Randomized; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; Upper arm; Vaccination

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. A multicenter, stratified, block-randomization, open-label trial to study the initial and persistant immune response to and safety of three hepatitis B vaccination schemas in HIV-infected adolescents 12 to < 25 years of age. The randomization will be balcnced with regard to CD4+T cell count of < 500 vs. > or equal to 500 cells/mL and no previous vs. one previous hepatitis B vaccination. Within each of the four strata, the subjects will be randomized so that at the end of each 6-subjects, exactly 2 subjects will have been selected to each of the three arms. The randomization will be restricted so that the percentage of subjects with CD4+ T cell count < or equal to 200 cells/mL will not exceed 15% of subjects on each arm.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 对于中心，这不一定是调查员的机构。 一项多中心，分层的，带有标签的开放标签试验，用于研究HIV感染的青少年在12至<25岁的HIV感染青少年中对三种丙型肝炎疫苗接种模式的初始和持续免疫反应和安全性。 关于CD4+T细胞计数<500 vs.>或等于500个细胞/mL，随机分组将均衡，并且以前没有一个先前的乙型肝炎疫苗接种。 在四个层中的每个阶层中的每个阶层中，受试者将被随机化，以便在每个6个受试者的末尾，将选择2个受试者，以选择2个受试者。 随机分组将受到限制，以使CD4+ T细胞计数的受试者的百分比<或等于200个细胞/mL的比例不会超过每个臂上受试者的15％。