A MULTICENTER, OPEN-LABEL PHASE I/II STUDY TO EVALUATE SAFETY AND IMMUNOGENICITY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项多中心、开放标签、平行分组的I/II期研究，旨在评估MVA-BN天花疫苗在有或没有接种天花疫苗的健康受试者中的安全性和免疫原性。总共150名受试者将根据艾滋病毒状况和以前的天花疫苗接种情况被分配到四个治疗组。含有1×108 TCID50的研究疫苗0.5mlMVA-BN将皮下注射。此前未接种天花疫苗的艾滋病毒感染者和健康人将每隔4周接种两次疫苗。此前接种过天花疫苗的艾滋病毒感染者和健康人将接受一次疫苗接种。研究持续时间为34至39周，包括5至7次访问。受试者将接受体检、心电图、不良事件收集以及安全性和免疫原性的实验室测试。

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. This is a multicenter, open-label, parallel-group Phase I/II study to evaluate safety and immunogenicity of MVA-BN smallpox vaccine in HIV infected subjects (with CD4 counts 350 / ¿l) with or without previous smallpox vaccination compared to healthy subjects with or without previous smallpox vaccination. A total of 150 subjects will be assigned to four treatment groups based on HIV status and previous smallpox vaccination status. The investigational vaccine 0.5 ml MVA-BN¿ containing 1x108 TCID50 will be administered subcutaneously. HIV infected subjects and healthy subjects who have not received smallpox vaccination previously will receive two vaccinations 4 weeks apart. HIV infected subjects and healthy subjects who have received smallpox vaccination previously will receive one vaccination. Study duration will be 34 to 39 weeks and include 5 to 7 visits. Subjects will undergo physical exams, electrocardiograms, adverse event collection, and laboratory testing for safety and immunogenicity.