A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects

Exclusion Criteria

• •1. Typical vaccinia scar
• •2. Known or suspected history of smallpox vaccination
• •3. History of vaccination with any poxvirus-based vaccine
• •4. US Military service before 1991 or after January 2003
• •5. Pregnant or breast-feeding women
• •6. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy
• •7. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial in the opinion of the investigator
• •8. History of or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded
• •9. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment
• •10. 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. Subjects with history of skin cancer must not be vaccinated at the previous tumor site
• •11. History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
• •12. Clinically significant mental disorder not adequately controlled by medical treatment
• •13. 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
• •14. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years
• •15. Twenty percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's Risk Assessment Tool: http://hin.nhlbi.nih.gov/atpiii/calculator.asp NOTE: This criterion applies only to subjects 20 years of age and older
• •16. Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months)
• •17. Known allergy to IMVAMUNE® vaccine and its constituents, e.g. tris(hydroxymethyl)-amino methane, including known allergy to egg or aminoglycoside (gentamycin)
• •18. History of anaphylaxis or severe allergic reaction to any vaccine
• •19. Acute disease (illness with or without a fever) at the time of enrollment
• •20. Body Temperature ≥ 100.4°F (38.0°C) at the time of enrollment
• •21. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after trial vaccination
• •22. Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after trial vaccination
• •23. Chronic systemic administration (defined as more than 14 days) of \> 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (Visit 5)
• •24. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy
• •25. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (Visit 5)
• •26. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine or planned administration of such a drug during the trial period (with the day of the FU call being considered the last day of the trial period).
• •27. Trial personnel