Special Access Program IMVAMUNE®
Condition: Vaccination
Intervention: IMVAMUNE®
Intervention description: IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of
      replicating vaccinia virus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a
             replicating vaccinia virus and who volunteer for the program. Subjects may be
             vaccinia-naïve or vaccinia-experienced.

          -  Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test
             within 48 hours prior to vaccination.

          -  WOCBP must have used an acceptable method of contraception for at least 30 days prior
             to the first vaccination and must agree to use an acceptable method of contraception
             during the vaccination period until at least 28 days after the last vaccination. A
             woman is considered of child-bearing potential unless post-menopausal or surgically
             sterilized. (Acceptable contraception methods are restricted to barrier contraceptives
             which include Food and Drug Administration (FDA)-approved spermicides, intrauterine
             contraceptive devices, or licensed hormonal products.)

          -  Read, signed and dated Informed Consent Form.

        Exclusion Criteria:

          -  Pregnant or breast-feeding women.

          -  Uncontrolled serious infection i.e., not responding to antimicrobial therapy.

          -  History of or active autoimmune disease. Persons with vitiligo or thyroid disease
             taking thyroid replacement are not excluded.

          -  Known or suspected impairment of immunologic function including, but not limited to,
             clinically significant liver disease; uncontrolled diabetes mellitus; moderate to
             severe kidney impairment or post organ transplant subjects.

          -  History of malignancy, other than squamous cell or basal cell skin cancer, unless
             there has been surgical excision that is considered to have achieved cure.

          -  History of coronary heart disease, myocardial infarction, angina, congestive heart
             failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood
             pressure, or any other heart condition under the care of a doctor.

          -  History of allergies or reactions to eggs, egg products, or gentamycin.

          -  Having received any vaccinations or planned vaccinations with a live vaccine within 28
             days or a killed vaccine within 14 days prior to or after IMVAMUNE®vaccination.

          -  Chronic administration (defined as more than 6 days) of systemic corticosteroids
             within 30 days of the first planned vaccination.

          -  Use of any investigational or non-registered drug or vaccine other than IMVAMUNE®
             within 30 days preceding the first vaccine dose.