VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Condition: Smallpox Vaccine Adverse Reaction
MeSH terms: Smallpox
Intervention: Vaccination with ACAM2000
Intervention description: In this study (VA-008), healthy adult male and female volunteers who meet the requirements for source plasma donors and study entry criteria will be vaccinated with the ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacture of VIGIV. There are possible risks associated with ACAM2000 vaccination. To ensure the safety of plasma donors, risk factor screening procedures and the collection of post-vaccination safety data will be assessed throughout the study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3032.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Objectives:

        -  To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune
           response resulting in high anti-vaccinia antibody titers. The collection of donor plasma
           will be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).

        -  To ensure the safety of plasma donors vaccinated with ACAM2000 through the
           implementation of risk factor screening procedures and the collection of
           post-vaccination safety data.
    

Eligibility criteria:

        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