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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 中心，但不一定是研究者所在的机构。 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岁初治和既往接种过疫苗的HIV感染受试者（CD 4计数）中的安全性和免疫原性 200 - 500/升 根据HIV状态和既往天花疫苗接种状态，将共计165例受试者分配至2个治疗组。 第1组将包括55名既往接种过和未接种过天花疫苗的健康受试者。 第2a组将包括20名CD 4计数350-500/L的HIV感染受试者，既往接种过或未接种过天花疫苗。 第2b组将包括90名CD 4计数200-500/L的HIV感染受试者，既往接种过或未接种过天花疫苗。 将皮下接种含1x 108 TCID 50的试验用疫苗0.5 ml MVA-BN？。 HIV感染受试者和健康受试者将接受两次疫苗接种，间隔4周。 研究持续时间为39周，包括7次访视。 受试者将接受体格检查、心电图、不良事件收集以及安全性和免疫原性实验室检测。

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.