Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine

Exclusion Criteria

• •1. Participation in another clinical study within the past month in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or planned concurrent participation in another clinical study during the study period
• •2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection, current hepatitis B/C infection,
• •3. Drug addiction including alcohol dependence
• •4. Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination (not more than 20g alcohol per day, which equals 0.5 L beer or 0.25 L of wine)
• •5. Persons who are accommodated in an institution on court or official order.
• •6. Persons in direct relationship with the sponsor, an Investigator or other study site staff. Direct relationship includes relatives or close dependents (children, spouse/partner, siblings or parents), as well as employees (site or sponsor).
• •7. Non-study licensed vaccines: vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine during the study period.
• •8. Measles vaccination or booster within the last 5 years or during the clinical study
• •9. Prior receipt of any Chikungunya vaccine
• •10. Blood donations during 1 month prior to Screening Visit and throughout the study
• •11. Recent infection (within 1 week prior to Screening Visit) (If non-serious, can be basis for temporary deferral)
• •12. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study
• •13. History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy.
• •14. History of autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease).
• •15. History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit.
• •16. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
• •17. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine.
• •18. History of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the volunteers
• •19. Clinically relevant abnormal laboratory values indicative of physical illness
• •* Hematology: hemoglobin, hematocrit, erythrocyte count, differential white blood count, platelets
• •* Chemistry: creatinine (≥1.7 mg/dL), potassium, sodium, calcium, aspartate transaminase/alanine aminotransferase (AST/ALT) ≥ 2.6 upper limit of normal (ULN), alkaline phosphatase, bilirubin
• •* Coagulation parameter: prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen according to the evaluation of the principle investigator
• •* Urinalysis according to the evaluation of the principle investigator
• •20. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers may affect the validity of the study except hormonal contraception in female subjects; prior to taking any medication during 72 h prior to the first vaccination, the study center should be consulted.
• •21. Immunosuppressive drugs: use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination, or anticipated use during the trial.
• •22. Receipt of blood products or immunoglobulins within 120 days prior to Screening Visit or anticipated receipt of any blood products or immunoglobulin during the trial.
• •23. Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child-bearing potential (for details please refer to section 8.3.6)
• •24. Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
• •25. Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women.
• •26. Inability or unwillingness to provide informed consent and to abide by the requirements of the study
• •27. Refusal to allow storage of specimens for future research.
• •28. Regular blood plasma donations