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: 7951093
• 负责人: LAWRENCE James D'ANGELO
• 金额: $ 0.56万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951093
• 关键词: Adolescent; CD4 Positive T Lymphocytes; Cell Count; Cells; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Funding; Grant; Hepatitis B Vaccination; Immune response; Institution; Randomized; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; Upper arm; open label

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 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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项多中心、分层、随机、开放标签试验，旨在研究三种乙肝疫苗接种方案对艾滋病毒感染青少年的初始和持久免疫应答及其安全性，疫苗接种浓度为12个细胞/毫升或等于500个/毫升，之前没有接种过乙肝疫苗或之前接种过一次乙肝疫苗。在四个层次中的每一个中，受试者将被随机化，这样在每个6个受试者结束时，正好有两个受试者被选择到三个手臂中的每一个。随机化将受到限制，这样CD4+T细胞计数或等于200个/毫升的受试者的百分比不会超过每组受试者的15%。