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.

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 一项多中心、分层、区组随机、开放标签试验，旨在研究12至< 25岁的HIV感染青少年对三种B型肝炎疫苗接种方案的初始和持续免疫应答以及安全性。 将根据CD 4 +T细胞计数≥ < 500 vs. >500个细胞/mL以及既往未接种与既往接种过一次B型肝炎疫苗来平衡随机化。 在4个分层中，将对受试者进行随机化，以便在每6例受试者结束时，3个组中的每一组将恰好选择2例受试者。 将限制随机化，以使每组中CD 4 + T细胞计数≤ 200个细胞/mL的受试者百分比不超过15%。