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.