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Rift Valley Fever Virus Vaccine Study (RVF001)

What is the purpose of this trial?

The purpose of this study is to test a new vaccine against the Rift Valley Fever Virus (RVFV) in healthy volunteers.

Rift Valley Fever (RVF) is an emerging disease caused by a virus carried by mosquito. It affects mainly cattle and livestock animals but has catastrophic consequences to human health as it can also be transmitted to people. The disease has serious implications for livestock, agriculture and trade as up to 90% of young animals affected by the disease will die. Although initially restricted to Africa, the virus can be transmitted by several different mosquito species that are more widely distributed than the virus itself, leading to concerns of disease spread as has occurred in the Arabian Peninsula and Madagascar. Humans can get infected through either infectious mosquito bites or contact with virus-contaminated tissues and fluids. In humans, RVFV infection usually causes a sudden illness with a fever. More severe cases can lead to bleeding disorders and severe neurological problems. In previous human outbreaks in East Africa and Saudi Arabia, 30% of the people who acquired the disease died. Long-term problems (e.g. impaired vision) were also observed in some of the survivors.

Vaccines against RVFV are available for livestock, but no licensed vaccines or specific treatments are currently available for humans.

RVFV is considered a global health threat with significant potential for international spread and use in bioterrorism. It has been prioritised for vaccine research and development by multiple public health and vaccine organisations around the world including: the World Health Organisation (WHO), the National Institute of Allergy and Infectious Diseases (NIAID) and the UK Vaccine Research & Development Network (UKVRDN).

The study will enable us to assess the safety of a new vaccine called ChAdOx1 RVF how well it makes an 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 15 participants to be vaccinated. 

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Trial Schedule

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Am I eligible to participate?

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FAQs

What does the trial involve?

The trial involves receiving one dose of a vaccine (ChAdOx1 RVF) and attending a series of follow-up visits after vaccination. You will be asked to fill in an online symptom diary for up to 4 weeks 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 RVFV 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 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 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.

For more details about the study, please read the information sheet

Interested in participating? Click here.