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VAC096 Trial: Malaria Vaccine Study

What is the purpose of this trial? 

 

R21/Matrix-MTM is a malaria vaccine developed by the University of Oxford which has been shown to protect against malaria.

This study will assess if a new administration schedule for R21/Matrix-MTM can lead to greater, longer lasting immune responses.


This study is being run at two trial centres:

  • Centre for Vaccinology and Tropical Medicine, Churchill Hospital site, Oxford 
  • NIHR Clinical Research Facility, 60 St Michael's Hill, Bristol

 

VAC096

          Malaria                                       Up to 14 Months                                  Up to 20 visits

 

Am I eligible to participate?

 

VAC096 Chart

 

Full eligibility details are contained in the participant information sheet.

 

FAQs

What does the trial involve?

Screening visit

Following an online pre-screening questionnaire, there will be an in-person screening visit. This takes place up to 3 months before the study starts.

It can last up to two hours with an opportunity for a short break. The purpose of the screening visit is for you to discuss the trial with us and decide if you still wish to take part. If you do, you will be asked to sign a consent form.

After signing the consent form:

  • You will be asked some medical questions.
  • A doctor will examine you.
  • Blood samples and a urine sample will be taken. These tests will need to be normal for you to be enrolled in the study.
  • If you are potentially able to become pregnant then you will have a urine pregnancy test.

 

Visits


You will receive between 2 and 6 vaccinations depending on your group allocation.

You will also have sampling of the lymph nodes in your armpit twice. You will attend 17 to 20 clinic
visits in total.


The exact vaccination and follow up schedule for each group are contained in the participant
information sheet.


Follow up visits and symptom tracking


You will be asked to fill in an electronic diary card to tell us about any symptoms you have
after vaccination and lymph node sampling. You will be required to have blood tests taken at
about half of the clinic 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 up to £2340.


What are the advantages of taking part?


This study will not benefit you. The information gained from the trial might help to prevent
malaria infection and disease in those who live in areas where malaria is common and in
travellers.


What are the risks of taking part?


R21/Matrix-MTM has been given to thousands of people before. There have been no major
concerns, such as illness, with R21/Matrix-MTM.

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

What will happen if I don’t want to carry on with the study?

You are free to withdraw from the study at any time without giving a reason.

 

What’s next?

 

Please read the full participant information sheet here.

If you are interested in taking part, please click here to apply via the pre-screening questionnaire

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