Zika Vaccine Study (ZIKA001)
What is the purpose of this trial?
The purpose of this study is to test a new vaccine against the Zika Virus (ZIKV) in healthy volunteers given on its own and at the same time as another new vaccine against Chikungunya Virus (CHIKV).
Zika is a disease caused by ZIKV and can be transmitted to humans through a mosquito bite, from a pregnant woman to their unborn child and it can also be sexually transmitted. Symptoms of Zika infection include fever, headache, joint & muscle pains, tiredness and skin rashes, but most people won’t have any symptoms at all. More than 85 countries have now reported Zika cases and the disease continues to spread globally. Zika is now part of the WHO list of priority diseases lists for accelerated vaccine research.
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. 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.
There are currently no available specific treatments or licensed vaccines for any of these 2 diseases. The development of new vaccines is the most cost-effective way to fight Zika and Chikungunya.
The study will enable us to assess the safety of new vaccines called ChAdOx1 Zika and ChAdOx1 Chik and the extent of their immune responses in healthy volunteers. This is the first trial to use this Zika vaccine and the second study to use the Chikungunya vaccine in humans. We plan to recruit a maximum of 57 participants to be vaccinated, where half of them will receive the Zika vaccine only and the other half will receive both vaccines.
The trial involves receiving one dose of one or 2 vaccines (ChAdOx1 Zika alone or ChAdOx1 Zika and 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.
Yes, you will be reimbursed at set rates for your time, inconvenience and travel which for this study will be approximately £415.
This study will not benefit you, but the information gained from the study might help to develop an effective Zika vaccine. However, during pre-trial assessment you will get information about your general health.
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.
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.