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

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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.