VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV

Inclusion Criteria: * Signed written informed consent. * Age 18 to 65. * Normal and healthy (immune competent) as determined by medical history, physical exam, vital signs and clinical laboratory tests during the screening period. * If all lab results for quantitative IgA immunoglobulin level are lower than 15% below normal range, the subject may not proceed further in the screening process. * Subject must meet all required subject suitability criteria that pertain to normal source plasma donors. * Negative HIV serology during screening period. * Subject must have been previously immunized for smallpox, at ≥3 years prior to commencement of screening assessments, and vaccination history must be confirmed by oral or written history and the presence of a visible pathognomonic smallpox vaccination scar. Exclusion Criteria: * History of severe related adverse event(s) from previous participation in VA-001 or VA-006 trials or to any smallpox vaccination. * The subject, or a household contact or other close/intimate contact of the subject has ANY of the following: * Eczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the investigator's discretion. * A history of immunodeficiency. * Currently or has recently received radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs. * Eye disease treated with topical steroids. * Known or suspected disorders of immunoglobulin synth…