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Saudi Arabia, Oxford University start 1st phase of new MERS vaccine clinical trial
Saudi Arabia’s King Abdullah International Medical Research Center (KAIMRC) and the University of Oxford’s Jenner Institute started Phase I clinical trial of a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
The trial – funded by the UK’s Department of Health and Social Care – will be the first Phase I clinical trial ever to be conducted in the Saudi kingdom and will provide valuable clinical data. Future development of the vaccine will be funded by the Coalition for Epidemic Preparedness Innovations (CEPI), a public-private coalition that aims to derail epidemics by speeding up the development of vaccines. CEPI will fund the vaccine for public health use. The commercial rights to the vaccine are held by Vaccitech a University of Oxford spin out company.
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 Saudi Arabia. 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 recognized 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 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 Saudi Arabia 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 immunize healthcare workers in regions where hospital outbreaks have occurred or to respond to an outbreak in a healthcare setting or community.
Professor Sarah Gilbert, UK project leader and Professor of Vaccinology at the Jenner Institute, said: ‘I congratulate KAIMRC on starting the first phase I clinical trial of a novel vaccine ever to take place in Saudi Arabia. It is appropriate that the trial is of a vaccine against Middle East Respiratory Syndrome. I look forward to continuing the fruitful collaboration between the Jenner Institute at Oxford University and KAIMRC.’
Naif Alharbi, vaccinologist and Co-PI on the Saudi MERS vaccine trial, said: ‘I am honored to lead the Oxford-KAIMRC collaboration that is now making historical progress as we are starting the first ever phase I clinical trial in Saudi Arabia for this vaccine. It is essential that we conduct phase I trials for MERS vaccines in Saudi Arabia where MERS-CoV is endemic and considered a national health research priority. I am also thrilled to have worked on the vaccine from lab and mice testing in Oxford and then to have been leading its development in camels and humans in Saudi Arabia. This trial will pave the way to further development of MERS vaccines. This trial also comes in time with our recent successful completion of evaluating the same vaccine in a camels in Saudi Arabia.’
Mohammad Bosaeed, ID consultant and PI on the Saudi MERS vaccine trial, said: ‘It is a great pleasure to lead the MERS vaccine phase I clinical trial, first ever Saudi phase I trial. We have also recently received approval for a state of the art clinical trial unit in our hospital (At the Saudi National Guard Health Affairs), first of its kind in the country. We are now recruiting for the study which assesses safety and immunogenicity of ChAdOx1-MERS vaccine in healthy subjects in Saudi Arabia. I have no doubt that this great milestone would open the doors for more clinical trials both in KAIMRC and in Saudi Arabia; we are excited and grateful for collaborating with Oxford University.’
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 program to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs). The views expressed are those of the authors and not necessarily those of the Department of Health and Social Care. The work was supported by the UK National Institute of Health Research (NIHR) through the Oxford Biomedical Research Center (BRC). The Coalition for Epidemic Preparedness Innovations (CEPI) provided funding for the extended 12 months’ follow-up in this study.
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