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

This is an interventional other trial for Smallpox Vaccine Adverse Reaction Read More

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.