| Eligibility |
Inclusion Criteria:
1. Healthy* ME adults aged 18 to 50 years
2. Able and willing (in the Investigator's opinion) to comply with all study requirements
3. Willing to allow the investigators to access the volunteer's medical history.
4. For females only, not planning to get pregnant during the study and a negative
pregnancy test on the day(s) of screening and vaccination. Effective methods of
contraception must be used. See section 6.3.3
5. Agreement to refrain from blood donation during the course of the study
6. Provide written informed consent
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.
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 use.
14. Suspected or known 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. History of exposure to MERS-CoV *
20. History of contact with camels. Defined as working in farms or barns; having been
within 6 feet (2 meters) of a sick camel without PPE; or consumption of raw milk or
uncooked meat. For this study, 30 days prior to screening will be considered.
21. History of allergic reaction to Aminoglycoside antibiotics. *rRT-PCR testing of
nasopharyngeal specimen , at the discretion of PI, may be indicated when a volunteer
is suspected to be asymptomatic carrier.
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