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

点击翻译按钮获取中文摘要

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.