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

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

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 synthesis.
  • Leukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Has 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 of childbearing potential must have negative pregnancy test prior to vaccination). Women of child-bearing potential (WOCBP) are temporarily excluded due to COVID.
• Household or other close/intimate contact(s) under the age of 12 months.
• History of allergies to phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluents.
• Subjects with kidney disease (except kidney stones).
• Subjects with abnormal EKG at screening (if applicable). To mitigate the risk of enrolling at risk subjects and potentially jeopardizing subject safety an EKG will be performed prior to vaccination with ACAM2000 smallpox vaccine in all potential subjects ≥50 years old and for all potential subjects <50 with two cardiac risk factors as listed immediately below including; severely or morbidly obese or higher obesity classification (BMI ≥36); high blood pressure; high blood cholesterol; diabetes or high blood sugar; a first degree relative who had a heart condition before the age of 50; and current tobacco smokers.

• Subject has three or more of the following risk factors:

  • Severely or morbidly obese or higher obesity classification (BMI ≥36)
  • 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 tobacco (cigarettes)

• Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including:

  • Arrhythmia
  • Syncope related to cardiac disease
  • Previous myocardial infarction
  • Angina
  • Coronary artery disease
  • Congestive heart failure
  • Cardiomyopathy
  • Stroke or transient ischemic attack
  • Myocarditis
  • Pericarditis
  • Chest pain or shortness of breath with activity (such as climbing stairs), peripheral edema, heart palpitations, dry cough, irregular heartbeat, excessive fatigue, unexplained syncope
  • Other heart conditions being treated by a physician