OPEN-LABEL TRIAL OF THREE HEPATITIS B VACCINATION SCHEMAS IN HIV-POSITIVE YOUTH

对艾滋病毒呈阳性的青少年进行三种乙型肝炎疫苗接种方案的开放标签试验

• 批准号: 7376308
• 负责人: Sue Ellen Abdalian
• 金额: $ 0.64万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376308
• 关键词: OPEN; LABEL; TRIAL; THREE; HEPATITIS

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 multi-center, stratified, block-randomized, open-label trial to study the initital and persistent immune response to and safety of three hepatitis B vaccination schemas in HIV-infected adolescents 12 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 200 cells/ml will not exceed 15% of subjects on each arm.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，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 500 个细胞/mL），以前没有接种过与以前接种过一次乙型肝炎疫苗接种。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，以便 CD4+ T 细胞计数为 200 个细胞/ml 的受试者百分比不会超过每组受试者的 15%。