HAV001 Vaccine Trial

What is the purpose of this trial?

The purpose of this study is to assess the new MAP vaccines, ChAdOx2 HAV and MVA HAV, at different doses. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving participants one or two vaccines in addition to doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans and we plan to recruit a maximum of 18 participants to be vaccinated.

What’s involved?

Number of visits: 7-12

Trial length: 3-5 months

Location: OX3 7LE

Am I eligible to participate?

You must:

  • Be aged 18-50 years old
  • Be in good health
  • Refrain from blood donation for the duration of the study

You must not:

  • Have previously received an investigational vaccine likely to impact on interpretation of the trial data

FAQs

What does the trial involve?

There are 3 study groups.  In the first two groups volunteers will receive one vaccination and 5 follow-up visits (involving a blood test), plus a final phone call. In the third group volunteers will receive two vaccinations 8 weeks apart and will attend 9 follow-up visits (involving a blood test), plus a final phone call.  Volunteers in all groups will be asked to complete a diary, recording any symptoms you experience after vaccination.

Is there any reimbursement for the trial?

Yes, we calculate reimbursement at a set rate for your time, travel and blood donation which for this study will be approximately £300-£530, depending on the trial group you participate in. Full details of reimbursement can be found in the trial information sheet.

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 vaccine against Crohn’s disease.

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.

  • Injection site pain (most likely mild; however there is a chance this could be moderate or severe in intensity).
  • Redness, swelling, itching and warmth at the vaccine site (symptoms are likely to be mild if present).
  • A ‘flu-like illness within 24 hours of vaccination which usually resolves within 48 hours. (This can include headache, muscle aches, joint aches, feverishness, tiredness, abdominal pain and feeling generally unwell). The majority of general symptoms are likely to be mild but there is a possibility of moderate or severe symptoms occurring.

Please refer to the trial information sheet for full details of procedures and potential risks.

What will happen if I don't carry on with the study?

If, at any time after agreeing to participate, you change your mind about being involved with this study you are free to withdraw without giving a reason. Your participation is voluntary and you are free to change your mind and withdraw at any time. You do not need to provide a reason. 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.

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

If you think you may be interested in participating in this trial, please complete our online pre-screen questionnaire.  A member of our team will then be in contact with you.