Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S
Condition: MERS (Middle East Respiratory Syndrome)
MeSH terms: Coronavirus Infections
Intervention: vaccine candidate MVA-MERS-S
Intervention description: vaccination with MVA-MERS-S in two escalating dose regimes
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; clinical phase 1; modified vaccinia Ankara vector; MERS-CoV

Summary:

      The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease
      with a reported lethality of up to 40% that is under tight epidemiologic control by the World
      Health Organization (WHO) and currently without registered prevention or treatment option.

      In this phase I first-in-human clinical trial, healthy volunteers in two different dose
      cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will
      additionally receive a late booster vaccination.

      The aim of the study is to assess the safety and tolerability of the candidate vaccine and to
      characterize its immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

        The participant must not be enrolled before all inclusion criteria (including test results)
        are confirmed. Subjects meeting all of the criteria listed below will be included in the
        study:

          1. Ability to understand the subject information and to personally sign and date the
             informed consent to participate in the study, before completing any study related
             procedures.

          2. Provided written informed consent.

          3. Healthy male and female participants aged 18 - 55 years inclusive at the time of
             consent. The date of signing informed consent is defined as the beginning of the
             screening period. This inclusion criterion will only be assessed at the first
             screening visit.

          4. No clinically significant health problems as determined during medical history and
             physical examination at screening visit.

          5. Body weight in defined relation to height. Body mass index 18.5 - 30.0 kg/m2 and
             weight >50 kg at screening.

          6. Females of child-bearing potential who agree to apply effective contraception methods
             (defined as a contraceptive method with failure rate of less than 1% per year when
             used consistently and correctly ) from at least 7 days prior to vaccination until the
             end of the study or females who are permanently sterilized (at least 6 weeks
             post-sterilization).

          7. Males who agree to apply effective contraception methods from day 0 through day 56.

          8. Be willing to refrain from blood donation during the course of the study.

          9. The subject is co-operative and available for the entire study.

        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.