A Phase 1 interventional study of ChAdOx1 MERS in Middle East Respiratory Syndrome Coronavirus, sponsored by King Abdullah International Medical Research Center. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by King Abdullah International Medical Research Center · Phase 1, Interventional, and Prevention
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
This is an open-label, dose escalation phase 1b trial to assess the safety and immunogenicity of the candidate ChAdOx1 MERS vaccine in healthy Middle Eastern adult volunteers aged 18-50. The first-in-human trial is now being conducted in Oxford in UK healthy adult volunteers. The vaccine will be administered intramuscularly.
Volunteers will be recruited and vaccinated at the King Abdulaziz Medical City, M-NGHA, Riyadh. There will be 3 study groups and a total of 24 volunteers will be enrolled. Staggered enrolment will apply for the first three volunteers within each group. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be allocated to a study group by selecting eligible volunteers for enrolment in the order in which they were deemed eligible, following screening.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 24 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →King Abdullah International Medical Research Center is the lead sponsor of 44 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
will be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS
Biological: ChAdOx1 MERS
will be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS
Biological: ChAdOx1 MERS
will be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS
Biological: ChAdOx1 MERS
a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
Occurrence of solicited and unsolicited local and systemic adverse events
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration
Time frame: 28 days following the vaccination
Measures of immunogenicity to the ChAdOx1 MERS vaccine
ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen
Time frame: 6.5 months following completion of the vaccination regimen
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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King Abdullah International Medical Research Center