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), 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.
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 honoured 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 programme 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 Centre (BRC). The Coalition for Epidemic Preparedness Innovations (CEPI) provided funding for the extended 12 months’ follow-up in this study.
About the trial
The trial will take place in King Abdullah International Medical Research Center (KAIMRC) and King Abdulaziz Medical City (KAMC), both are under the Ministry of National Guard Health Affairs (Saudi NGHA). KAMC in Riyadh has been recognised as a distinguished healthcare provider in Saudi Arabia and the region, with a bed capacity of 1501, commenced its operations in May 1983. Since then, it has continued expanding, while providing services for a rapidly growing patient population in all of its catchments areas. Recently KAIMRC and KAMC has received approval for phase I clinical trial unit from the national regulator (Saudi FDA).
Situation of MERS-CoV
At the end of September 2019, a total of 2468 laboratory-confirmed cases of Middle East respiratory syndrome (MERS), including 851 associated deaths (case–fatality rate: 34.4%) were reported globally; the majority of these cases were reported from Saudi Arabia (2077 cases, including 773 related deaths with a case–fatality rate of 37.2%).
The number of cases reported in KSA this year was more than 2018, but significantly less than the 2014-2017 corresponding period.
“In one study 54.9% of primary cases were associated with direct camel exposure.” Ref: Reported Direct and Indirect Contact with Dromedary Camels among Laboratory-Confirmed MERS-CoV Cases. Conzade R et al. (Viruses. 2018 Aug 13;10(8). PMID: 30104551).
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.