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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · University of Oxford
interventional
24
1 country
1
Study Start
December 17, 2019
Actual (reported)Primary Completion
November 26, 2020
Actual (reported)Study Completion
November 26, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 26, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 14, 2019
Actual (reported)November 20, 2019
Actual (reported)December 17, 2019
Actual (reported)November 26, 2020
Actual (reported)November 26, 2020
Actual (reported)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
28 days following the vaccination
Measures of immunogenicity to the ChAdOx1 MERS vaccine
6.5 months following completion of the vaccination regimen
will be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS
will be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS
will be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS
a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, 11426, Saudi Arabia
Bosaeed M, Balkhy HH, Almaziad S, Aljami HA, Alhatmi H, Alanazi H, Alahmadi M, Jawhary A, Alenazi MW, Almasoud A, Alanazi R, Bittaye M, Aboagye J, Albaalharith N, Batawi S, Folegatti P, Ramos Lopez F, Ewer K, Almoaikel K, Aljeraisy M, Alothman A, Gilbert SC, Khalaf Alharbi N. Safety and immunogenicity of ChAdOx1 MERS vaccine candidate in healthy Middle Eastern adults (MERS002): an open-label, non-randomised, dose-escalation, phase 1b trial. Lancet Microbe. 2022 Jan;3(1):e11-e20. doi: 10.1016/S2666-5247(21)00193-2. Epub 2021 Nov 3.
Mohammad Bosaeed, MD
Ministry of National Guard-Health Affairs (MNGHA)
24 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2019
First Posted
November 20, 2019
Study Start
Contact the study team to confirm eligibility.
December 17, 2019
Primary Completion
November 26, 2020
Actual (reported)Study Completion
November 26, 2020
Actual (reported)Last Updated
December 1, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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