MERS-CoV Study Trial (MERS001)
What is the purpose of this trial?
The purpose of this study is to test a new vaccine against the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), in healthy volunteers.
MERS-CoV has been identified as one of the most worrying newly emerging outbreak diseases by many global agencies and expert groups, including the World Health Organization (WHO). This disease is now endemic in Saudi Arabia and some other countries in the Middle East with spread to many other regions including a recent outbreak in South Korea. More than 2458 cases of severe acute respiratory disease; with 848 deaths in 27 countries have been reported, including the UK. The disease is caused by MERS coronavirus and is spread by droplet infection of the airways. Those at particular risk of death are the elderly or immunocompromised. Currently there is no approved vaccine for MERS-CoV.
The study will enable us to assess the safety of the vaccine and the extent of the immune response in healthy volunteers. We will do this by giving participants one dose of the vaccine in addition to doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use this vaccine in humans and we plan to recruit a maximum of 48 participants to be vaccinated.
What does the trial involve?
The trial involves receiving one dose of a vaccine (ChAdOx1 MERS) and attending a series of follow-up visits after vaccination. You will be asked to fill in an electronic diary card to tell us about any symptoms you have after vaccination and will be required to have blood tests at most of the follow-up visits.
Is there any reimbursement for the trial?
Yes, you will be reimbursed at set rates for your time, inconvenience and travel which for this study will be up to £715 dependent on which group you are in.
What are the advantages of taking part?
By taking part, you will contribute to the knowledge gained from this study, which might be a step closer to developing an effective vaccine against MERS-CoV. You will also be able to get information about your general health during the pre-enrolment process.
Are there any risks from taking part in the study?
We do not expect the side effects to be significantly different from numerous trials we have conducted using similar vaccines. Please refer to the trial information sheet for full details of procedures and potential risks.
What will happen if I don’t want to carry on with the study?
Participation is voluntary and you are free to change your mind and withdraw at any time. This will not affect your subsequent medical care in any way. If you withdraw we might need to offer you a follow up visit, for example to check the vaccination site or a blood result. Your compensation would be paid as a proportion of the total compensation according to the length of your participation.