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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Saudi Arabia
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
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