Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area
Condition: Chikungunya
MeSH terms: Chikungunya Fever
Intervention: MV-CHIK; MMR-vaccine
Intervention description: Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose; Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, comparator controled, randomized, double-blinded, interventional, safety study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All subjects will receive two intramuscular injections on day 0 and 28 and one subcutaneous injection on day 0.
Subjects randomized to verum will receive MV-CHIK intramuscularely on days 0 and 28 and placebo subcutaneously in the contralateral arm on day 0.
Subjects randomized to the comparator will receive MMR-vaccine subcutaneously on day 0 and placebo (dummy injection) intramuscularely on days 0 and 28 in the contralateral arm.
Enrollment: 34.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a
      previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will
      be assessed.

      MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will
      receive MV-CHIK; 20% will receive MMR vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged ≥21 to ≤50 years on the day of enrollment.

          2. Able to provide informed consent.

          3. Available and accessible for the duration of the trial.

          4. Able and willing to comply with all requirements of the study.

          5. For female subjects, willing to practice a reliable form of contraception as specified
             in the protocol until five months after the second and final vaccination in accordance
             with recommendations following MMR vaccination.

          6. Medical history and physical examination findings are considered normal or not
             clinically significant in the opinion of the Investigator.

          7. Laboratory values are considered normal or not clinically significant in the opinion
             of the Investigator.

          8. History of previous measles vaccination, either in childhood or as an adult if more
             than three months before participation in this study.

        Exclusion Criteria:

          1. Taking medication or other treatment for unresolved symptoms attributed to a previous
             chikungunya virus infection.

          2. Prior receipt of any chikungunya or other alphavirus vaccine.

          3. Recent infection, including suspected chikungunya (within 1 week prior to Screening
             Visit).

          4. History of an allergic or anaphylactic reaction to any vaccine.

          5. An allergic reaction other than allergic contact dermatitis to any component of either
             vaccine (i.e., neomycin, gelatin), or a current egg allergy. Volunteers with a
             childhood history of egg allergy who are able to tolerate egg in their diet now will
             not be excluded on this basis.

          6. History of an immunosuppressive disorder (such as human immunodeficiency virus [HIV]
             infection, common variable immunodeficiency), chronic infection (such as chronic
             hepatitis B or C), autoimmune disease (such as rheumatoid arthritis, systemic lupus
             erythematosus [SLE], autoimmune thyroid disease) or any medical condition that, in the
             opinion of the Investigator, could lead to an atypical immune response to the vaccine.

          7. History of moderate or severe non-traumatic arthritis or arthralgia within 3 months of
             the Screening Visit.

          8. Recent (within 30 days), current or anticipated use of any immunosuppressive or immune
             modifying medication including corticosteroids (excluding nasal, ophthalmic, and other
             topical preparations).

          9. Other vaccination or planned vaccination within 4 weeks of either study dose (seasonal
             influenza vaccine excepted).

         10. Measles vaccination or booster within the last 3 months or planned during the clinical
             study.

         11. Receipt or planned receipt of blood products including immunoglobulins within 120 days
             of the Screening Visit.

         12. Pregnant or lactating or planning pregnancy during the trial.

         13. Known alcohol or other substance abuse that in the opinion of the Investigator affects
             the ability or willingness of the participant to understand and comply with the study
             protocol.

         14. Participation in another clinical study within the past 30 days in which the subject
             was exposed to an investigational product (pharmaceutical product or placebo or
             device) or planned concurrent participation in another clinical study during the study
             period.

         15. Relevant history of any medical condition that, in the opinion of the Investigator,
             may interfere with the safety of the subject (volunteer) or aims of the study.

         16. History of neoplastic disease (excluding successfully treated non-melanoma skin cancer
             or cervical intraepithelial neoplasia) within the past 5 years or a history of any
             hematological malignancy.

         17. Behavioral or psychiatric disease or cognitive impairment that in the opinion of the
             Investigator affects the ability or willingness of the participant to understand and
             comply with the study protocol.

         18. Non-consent to storage of blood specimens for future research.

         19. Persons in direct relationship with the Sponsor or its contract service provider, the
             clinical research organization (CRO) or its subcontractors, the Investigator or study
             site staff. Direct relationship includes first degree relatives or dependents
             (children, spouse/partner, siblings or parents), as well as employees (site or
             Sponsor). Employees of the University of Puerto Rico not directly employed by the
             Clinical & Translational Research Center will not be excluded.

         20. Any condition that would, in the opinion of the site Investigator, place the subject
             at an unacceptable risk of injury or render the subject unable to meet the
             requirements of the protocol.