MERS vaccine clinical trial starts in Saudi Arabia
The King Abdullah International Medical Research Centre (KAIMRC), in collaboration with the University of Oxford’s Jenner Institute has started a Phase I clinical trial in the Kingdom of Saudi Arabia (KSA) for a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
The trial will be the first Phase I clinical trial ever to be conducted in the KSA and will provide valuable clinical data. The trial is a collaboration between the Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC https://kaimrc.med.sa/ ), funded by the Department of Health and Social Care. MERS-CoV causes an emerging zoonotic (transmitted from animals to humans) viral respiratory disease that was first described in 2012 and is now endemic in KSA. MERS-CoV infection can be asymptomatic or can result in severe acute respiratory distress and death.
MERS-CoV has spread to different countries in the Middle East and other regions with 2458 laboratory confirmed cases of MERS-CoV infection including 851 deaths in 27 countries reported, as of September 2019. MERS-CoV poses a significant threat to public health security based on its epidemic potential and lack of currently available effective countermeasures and has been listed as a priority pathogen for research and development by the World Health Organization (WHO) and other health agencies around the globe.
Dromedary camels are now recognised as the source of zoonotic infections. In one study 54.9% of primary cases were associated with direct camel exposure. Human to human transmission, especially in hospitals, has been responsible for the majority of cases seen in recent outbreaks.
The Phase I trial in KSA will replicate the design of the initial study performed in Oxford. In the Oxford trial of the ChAdOx1 MERS vaccine, 24 healthy adult volunteers aged 18-50 years received a single dose of vaccine with the aim of assessing safety and tolerability of ChAdOx1 MERS. ChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to induce immune responses against MERS-CoV.
It is hoped that the trial in KSA will provide additional data to support these findings, and conducting a clinical trial in a disease endemic region is an important step in vaccine development. A vaccine against MERS-CoV could be used to prevent zoonotic transmission, especially in those frequently exposed to camels in the Middle East, to immunise healthcare workers in regions where hospital outbreaks have occurred or to respond to an outbreak in a healthcare setting or community.
This research was funded by the Department of Health and Social Care (project number:16/107/01) as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs). The work was supported by the UK National Institute of Health Research (NIHR) through the Oxford Biomedical Research Centre (BRC). The Coalition for Epidemic Preparedness Innovations (CEPI) provided funding for the extended 12 months’ follow-up in this study.