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

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、对照的II期研究，旨在评价MVA-BN？天花疫苗在18-55岁未接种过CD4200-500个/L的HIV感染者和既往接种过天花疫苗的受试者中的安全性和免疫原性。第一组将包括55名健康受试者，是否接种过天花疫苗。2a组将包括20名HIV感染者，CD4350-500/？L，有无接种过天花疫苗。2b组将包括90名HIV感染者，CD4200-500/？L，有无接种过天花疫苗。含有1×108 TCID50的研究疫苗0.5mlMVA-BN将皮下注射。HIV感染者和健康人将每隔4周接种两次疫苗。学习时间为39周，包括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, controlled phase II study to evaluate safety and immunogenicity of MVA-BN¿ smallpox vaccine in 18-55 year old naive and previously vaccinated HIV infected subjects with CD4 counts 200 - 500/¿l. A total of 165 subjects will be assigned to 2 treatment groups based on HIV status and previous smallpox vaccination status. Group 1 will include 55 healthy subjects with and without previous smallpox vaccination. Group 2a will include 20 HIV infected subjects with CD4 counts 350-500/ ¿l, with and without previous smallpox vaccination. Group 2b will include 90 HIV infected subjects with CD4 counts 200-500/¿l, with and without previous smallpox vaccinations. The investigational vaccine 0.5 ml MVA-BN¿ containing 1x108 TCID50 will be administered subcutaneously. HIV infected subjects and healthy subjects will receive two vaccinations 4 weeks apart. Study duration will be 39 weeks and include 7 visits. Subjects will undergo physical exams, electrocardiograms, adverse event collection, and laboratory testing for safety and immunogenicity.