Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria are met at screening or at day -1:
• •1. Prior receipt of a MERS vaccine or MVA immunizations.
• •2. Receipt of any vaccine in the 2 weeks prior to 1st trial vaccination (4 weeks for live vaccines) or planned receipt of any vaccine in the 3 weeks following the 2nd trial vaccination.
• •3. Known allergy to the components of the MVA-MERS-S vaccine product as eggs, chicken proteins, and gentamycin or history of life-threatening reactions to vaccine containing the same substances.
• •4. Participation in a clinical trial or use of an investigational product within 30 days or five times the half-life of the investigational drug -whichever is longer- prior to receiving the first dose within this study.
• •5. Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product under investigation.
• •6. Any positive result for human immunodeficiency virus (HIV)1/2 antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg) testing.
• •7. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
• •8. Participants with inflammatory, infectious and neuroinflammatory underlying disease which could cause an expected impairment of the blood brain barrier such as meningitis, multiple sclerosis, epilepsy, or Alzheimer's disease.
• •9. Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child.
• •10. Known history of Guillain-Barré Syndrome.
• •11. Active malignancy or history of metastatic or hematologic malignancy.
• •12. Suspected or known alcohol and/or illicit drug abuse within the past 5 years.
• •13. Moderate or severe illness and/or fever \>38°C within 1 week prior to vaccination.
• •14. Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period.
• •15. History of blood donation within 60 days of enrollment or plans to donate within the treatment phase (until the 2nd vaccination).
• •16. Receipt of chronic (defined as more than 14 days) immune suppressants or other immune-modifying drugs within 6 months of study inclusion (screening).
• •* For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day.
• •* Intranasal and topical steroids are allowed.
• •17. Participants with skin lesions close to the injection site or active oral lesions will be excluded.
• •18. Thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment.
• •19. Participants with a significant infection or known inflammation.
• •20. History of relevant cardiovascular disorders or evidence of hyper- (sitting blood pressure systolic \>140 or diastolic \>90 mmHg) or hypotension (sitting blood pressure systolic \<90 or diastolic \<40 mmHg) at screening.
• •21. Subjects who are known or suspected not to comply with the study directives.
• •22. Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.