The purpose of this study is to test a new vaccine against the Chikungunya Virus (CHIKV) in healthy volunteers.
Chikungunya fever is a disease caused by CHIKV and it is transmitted to humans through a mosquito bite. It has been identified in over 100 countries in Asia, Africa, Europe, Oceania and the Americas, causing approximately 1 million cases per year worldwide. The disease typically consists of an acute illness characterised by fever, skin rash, muscle aches and severe joint pains (which are often incapacitating), lasting weeks to months or in rare cases, years.
The mosquito involved in the transmission of the CHIKV can also be found in temperate regions and has a wider geographic distribution than the virus itself at this time. CHIKV is listed as priority virus by the UK Vaccine Network and the US National Institute of Allergy and Infectious Diseases. It has also been designated as a serious condition requiring action by the WHO to promote Research and Development to control future outbreaks. In 2017, outbreaks of Chikungunya fever in Italy and southern France have been reported. There are currently no available treatments or licensed vaccines and strategies tackling the control of the mosquito are extremely difficult to implement. Fatal cases are rare, but they have been observed in new-born and elderly individuals, as well as in those with medical conditions such as diabetes or cardiovascular, respiratory, and neurologic disorders
The study will enable us to assess the safety of the new vaccine called ChAdOx1 Chik 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 24 participants to be vaccinated.
What does the study involve?
The trial involves receiving one dose of a vaccine (ChAdOx1 Chik) 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 approximately £370.
What are the advantages of taking part?
This study will not benefit you, but the information gained from the study might help to develop an effective CHIKV vaccine. However, during pre-trial assessment you will get information about your general health.
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 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 safety purposes, 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.