Persistence of the immune response after immunisation with Ebola virus vaccines (PRISM Study)

The Oxford Vaccine Group is inviting participants of the ‘Evaluating Optimal Vaccine Schedules against Ebola’ (EVOLVE) vaccine study to take part in a study looking at the persistence of immunity induced by the vaccines administered in that study (Ad26.ZEBOV and MVA-BN-Filo).

This study would involve two clinic visits, at which you would have a blood test and any relevant medical information would be collected. Participants who completed both their prime and boost vaccinations will be invited for two study visits. Both visits will be completed within 24-60 months after you received your first Ebola vaccines and must be at least 6 months apart.

This study will help us collect new information on how well these vaccines might be able to provide long term protection against Ebola Virus disease.

What is this study about?

This study proposes to investigate whether the immune response generated following vaccination with various prime boost regimes of the Ad26-ZEBOV and MVA-BN-Filo Ebola vaccines is preserved in the long term.

What is involved?

We are aiming to recruit up to 148 study participants who received active vaccines in the phase 2 study. This study involves two clinic visits, where a blood sample will be taken to assess immunity.

At the initial visit the study will be discussed in detail. Participants will be given the opportunity to ask questions and explore their concerns. Participants willing to proceed with the study will be consented, followed by screening for inclusion and exclusion criteria. Study participants will then undergo a blood test. The initial visit is likely to last for 30-45 minutes.

At the second study visit, medical information will be collected and a blood test taken. This visit is likely to last about 30 minutes.

Who do we want for volunteers?

We plan to recruit participants who are healthy and have received both vaccines (Ad26.ZEBOV/MVA-BN-Filo) in the phase 2 trial.

We would not want to recruit anyone with significant health issues, anyone who has problems with their immune system, anyone who has had a visit to an Ebola endemic area since the phase 2 study or anyone who has received adenovirus or MVA virus based vaccine since the previous study.

Reimbursement

All participants will be reimbursed for their time, travel and for inconvenience based on the following figures:

 

Amount per visit

Travel expenses

£15

Inconvenience of blood test

£10

Time required for visit

£20

Each participant will be reimbursed £45 per visit.

Confidentiality

The study staff will ensure that participants’ anonymity is maintained. Any electronic databases and documents with participant identifying details will be stored securely and will only be accessible by study staff and authorised personnel. The study will comply with the Data Protection Act, which requires data to be anonymised as soon as it is practical to do so.

What happens if I’m interested in taking part?

Thank you for considering taking part in this study. If you are interested in taking part, you will need to read the information booklet. Please note that entering your details and obtaining a copy of the Study Information Booklet does not commit you to participating in the study.

Study Information Booklet web link

Biobank Study Information Booklet

What do I do next?

To let the study team know you would like to participate, please complete the form below to let us know you are interested. Alternatively, you can call us on 01865 611400 or email us at info@ovg.ox.ac.uk.

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