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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
. Any history of anaphylaxis in relation to vaccination
. Pregnancy, lactation or willingness/intention to become pregnant during the study