Phase I Trial of Measles Vectored Chikungungya Vaccine

Exclusion Criteria

• •1. History of known chikungunya infection.
• •2. Previous vaccination with an investigational chikungunya vaccine.
• •3. Past residence in, or travel for greater than 1 consecutive month within the past 6 months to, a location known to have local CHIKV transmission. (Examples of countries with local chikungunya virus transmission include, but are not limited to, countries in sub-Saharan Africa, South Asia, the Indian and Pacific Ocean). Residence in or travel to Central and South America, the Caribbean, Florida, Puerto Rico and the U.S. Virgin islands, if prior to 2013, will be permitted.
• •4. Plan to travel to a location known to have local CHIKV transmission during the course of the study or history of travel to one of these countries within 30 days prior to screening. Travel to Florida will be permitted. Those planning travel to Florida will be provided information on mosquito bite protection.
• •5. Body temperature \>/ =100 °F (\>/ =37.8°C) or acute illness within 3 days before study injection days (subject may be rescheduled).
• •6. A positive serum or urine pregnancy test at screening or within 24 hours prior to study injection, women who are planning to become pregnant, or women who are breastfeeding. If female of childbearing potential as defined in Inclusion Criterion 3. From 30 days prior to entering the study until 85 days after the final study injection.
• •7. Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation. E.g., History of seizure disorders (other than febrile seizures as an infant), autoimmune disease, immunodeficiency, any spleen disease, active malignancy, active asthma, known cardiac disease, pulmonary disease, liver disease, renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients.
• •8. History of thrombocytopenia, idiopathic thrombocytopenic purpura or other platelet disorder.
• •9. A history of chronic arthritis or chronic arthralgia symptoms.
• •10. Used an immunosuppressive or immunomodulatory drug for 2 or more consecutive weeks within 6 months prior to the first study injection (nasal and topical steroids are allowed). Such as \>/ =20 mg total dose/day of prednisone orally or \> 840 µg of inhaled beclomethasone.
• •11. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt.
• •12. A history of treatment for any other psychiatric disorder in the past 3 years that increases the risk to the subject in the opinion of the investigator Treatment for mild depression or anxiety using a single antidepressant or anti-anxiety medication will be allowed so long as the subject has been on stable doses for 3 months.
• •13. Received immunoglobulin or other blood product within 3 months prior to enrollment or planned receipt of immunoglobulin or a blood product through study day 169 following the second dose of vaccine.
• •14. Received or plan to receive any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks of any study injection.
• •15. Received or plans to receive measles-containing vaccine within 3 months prior to enrollment or planned to receive through study day 29 following the second dose of vaccine. measles, mumps, rubella vaccine.
• •16. History of anaphylaxis or severe allergic reaction to vaccines or history of allergic reaction to any components in the MV-CHIK vaccine.
• •17. Received an experimental or investigational agent within 1 month before study injections or expectation to receive an experimental agent through 6 months following the last study injection. Vaccine, drug, biologic, device, blood product, or medication.
• •18. Any condition that would, in the opinion of the investigator, place the subject at an unacceptable injury risk, render him/her unable to meet the requirements of the protocol, or that may interfere with successful study completion.
• •19. A history of alcohol or drug abuse during the previous 3 years For example, daily excessive alcohol or marijuana use or frequent binge drinking as determined by the investigator.
• •20. Presence of tattoos that, in the opinion of the investigator, would preclude evaluation of the injection site.