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资助的中心赠款提供的资源的许多研究子项目之一。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。列出的机构适用于该中心，这不一定是调查员的机构。一项多中心，分层，嵌入式，开放标签的试验，用于研究HIV感染的青少年在12至500个细胞/mL中对三种乙型肝炎疫苗接种式架构的发挥和持续的免疫反应和安全性，并且没有以前的肝炎疫苗。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200细胞/mL受试者的百分比不超过每个手臂受试者的15％。