VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

Inclusion criteria

• Signed written informed consent.
• Age 18 - 65 years.
• Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests at screening visit.
• Subject must meet all required subject suitability criteria that pertain to normal Source Plasma donors.
• Subject must have been previously immunized for smallpox, at ≥1 year prior to commencement of screening assessments for the VA-006 trial, and vaccination history must be confirmed by oral or written history AND the presence of a visible pathognomonic smallpox vaccination scar.
• Female subjects of childbearing potential must use at least one of the following means of birth control documented by a physician's letter:

• Surgical sterilization
• Hormonal (oral/injectable/implant) for at least 30 days prior to vaccination
• Intrauterine device (IUD) inserted at least 7 days prior to vaccination.
• Female subjects who are not using one of the methods of birth control listed above must be documented as postmenopausal, which is defined as not having a menstrual period for longer than 12 months and having a serum follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL.

Exclusion criteria

• History of severe adverse event(s) from previous participation in the VA-001 or VA-005 trials or any other smallpox vaccination program/study.
• Subject, household contact, or other close/intimate contact:

• with eczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the Investigator's discretion.
• with a history of immunodeficiencies (see section 7.1.2 of the protocol).
• who received radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs.
• with eye disease treated with topical steroids.
• with known or suspected disorders of immunoglobulin synthesis.
• with leukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
• with a history of adverse reactions to smallpox (vaccinia) vaccine.
• has recently been diagnosed with cancer and who will be undergoing chemotherapy or radiation therapy during the vaccination healing time.
• is a transplant recipient (except for corneal transplant).
• is pregnant, planning pregnancy or breast feeding (female subjects must have negative serum pregnancy test at screening and negative urine pregnancy test prior to vaccination).
• Household or other close/intimate contact(s) under the age of 12 months.
• History of allergies to latex, phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluent
• Severely or morbidly obese or higher obesity classification (BMI ≥ 35).
• Subjects with abnormal EKG and/or cardiac Troponin levels at screening.
• Subjects with cancer or kidney disease (except kidney stones).
• Subject has 3 or more of the following risk factors:

• High blood pressure diagnosed by a doctor
• High blood cholesterol diagnosed by a doctor
• Diabetes or high blood sugar diagnosed by a doctor
• A first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50
• Currently smokes cigarettes
• Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including:

• Arrhythmia
• Syncope
• Previous myocardial infarction
• Angina
• Coronary artery disease
• Congestive heart failure
• Cardiomyopathy
• Stroke or transient ischemic attack
• Chest pain or shortness of breath with activity (such as walking up stairs)
• Other heart conditions being treated by a physician.