A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine… (NCT04170829) | Clinical Trial Compass
CompletedPhase 1
A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)
Saudi Arabia24 participantsStarted 2019-12-17
Plain-language summary
A phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern volunteers
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Healthy\* ME 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 access the volunteer's medical history.
✓. 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
✓. 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.
✕. 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)
✕. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
What they're measuring
1
Occurrence of solicited and unsolicited local and systemic adverse events
Timeframe: 28 days following the vaccination
Trial details
NCT IDNCT04170829
SponsorKing Abdullah International Medical Research Center