Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)

Exclusion Criteria

• •1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
• •2. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine).
• •3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
• •4. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
• •5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
• •6. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
• •7. Any history of anaphylaxis in relation to vaccination
• •8. Pregnancy, lactation or willingness/intention to become pregnant during the study
• •9. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• •10. History of serious psychiatric condition likely to affect participation in the study
• •11. Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
• •12. Any other serious chronic illness requiring hospital specialist supervision
• •13. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• •14. Suspected or known injecting drug abuse in the 5 years preceding enrolment
• •15. Seropositive for hepatitis B surface antigen (HBsAg)
• •16. Seropositive for hepatitis C virus (antibodies to HCV)
• •17. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
• •18. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
• •19. Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
• •20. Prior exposure to CHIKV (serology will be requested at the discretion of the investigator)
• •21. Travel to a CHIKV endemic region throughout the duration of the participants enrolment in the Study and within the preceding 30 days.