Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001) (NCT03399578) | Clinical Trial Compass
TerminatedPhase 1
Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001)
Stopped: The scientific questions proposed remain relevant, but will now be addressed in a larger phase II immunogenicity trial of the ChAdOx1 MERS vaccine given at 2 doses.
United Kingdom29 participantsStarted 2018-03-14
Plain-language summary
This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone both as a single administration and with a homologous prime-booster.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Healthy adults aged 18 to 50 years
✓. Able and willing (in the Investigator's opinion) to comply with all study requirements
✓. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner or access this medical history electronically.
✓. For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination
✓. Agreement to refrain from blood donation during the course of the study
✓. Provide written informed consent
Exclusion criteria
✕. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
✕. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine).
✕. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
✕. 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)
✕
What they're measuring
1
Occurrence of solicited and unsolicited local and systemic adverse events