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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 一项多中心、分层、分组随机、开放标签试验，研究 HIV 感染青少年对三种乙型肝炎疫苗接种方案的初始和持续免疫反应以及安全性（12 至或等于 500 个细胞/mL，以前没有接种过 1 个）既往接种过乙型肝炎疫苗。 在四个层中的每一层中，受试者将被随机化，以便在每 6 名受试者结束时，将恰好 2 名受试者被选择到三个组中的每一个中。 随机化将受到限制，使得 CD4+ T 细胞计数或等于 200 个细胞/mL 的受试者百分比不会超过每组受试者的 15%。