Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Intervention: MV-CHIK low dose; MV-CHIK high dose; Priorix®; physiological saline solution
Intervention description: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose; recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose; lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection; sterile physiological saline solution 0.9% used as placebo
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chikungunya, infectious disease

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine
      against Chikungunya virus after one or two vaccinations by comparison of two different dose
      levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent obtained before any trial-related activities.

          2. Ability to comprehend the full nature and purpose of the study, including possible
             risks and side effects; ability to cooperate with the investigator and to comply with
             the requirements of the entire study

          3. Available for the duration of the trial

          4. Healthy men or women aged >18 and <55 years

          5. In female subjects either childbearing potential terminated by surgery or one year
             post-menopausal, or a negative urine pregnancy test during screening and the
             willingness not to become pregnant during the entire study period by practicing
             reliable methods of contraception as specified in protocol

          6. Normal findings in medical history and physical examination or the investigator
             considers all abnormalities to be clinically irrelevant

          7. Normal laboratory values or the investigator considers all abnormalities to be
             clinically irrelevant (unless otherwise specified in exclusion criteria)

        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