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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项多中心、分层、随机、开放标签的试验，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，接种细胞数为12-500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细胞计数为200个/毫升的受试者的百分比不会超过每组受试者的15%。

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.