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

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。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。一项多中心、分层、区组随机、开放标签试验，旨在研究HIV感染青少年（12 - 500个细胞/mL）对三种B肝炎疫苗接种方案的初始和持续免疫应答以及安全性，既往未接种过与既往接种过一次B肝炎疫苗。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。随机化将受到限制，因此每组中CD 4 + T细胞计数200个细胞/ml的受试者百分比不超过15%。

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.