VAC089 Trial: Malaria Vaccine Study

VAC089 Trial: Blood Stage Malaria Vaccine

 

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WHAT IS THE PURPOSE OF THIS TRIAL?

 

The trial website can be found here.

The purpose of this study, which is being hosted at the Jenner Institute, to assess two experimental malaria vaccines for their safety. We will also look at the body’s immune response to the vaccines. The vaccines we are testing in this study are called “R78C” and “RH5.1”. They are given with an adjuvant called “Matrix-M”. This is a substance to improve the body’s response to a vaccination.

The aim is to use the vaccines and adjuvant to help the body make an immune response against parts of the malaria parasite to prevent it from getting into the blood cells and so stop malaria from causing illness.

 

 

 

 

 

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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 3 or 4 vaccinations depending on your group allocation and attend 19 to 23 visits in total.

Volunteers will be reviewed in clinic the day after each of the three vaccinations and then at one week, two weeks and four weeks post-vaccination. In addition to this there are 4-5 further clinic appointments, up to 18 months after the final vaccination.

Visits will take place at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). This is at the Churchill Hospital in Oxford.

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 will be required to have blood tests taken 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 £925 or £1,135 (depending on group allocation).

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. There are other malaria vaccines in various stages of development.

What are the risks of taking part?

R78C is being tested for the first time in people in this trial. However, we do not expect the side effects of this vaccine to be much different to similar vaccines.

RH5.1 has been given to over 100 people. Matrix-M has been given to tens of thousands of adults, in combination with other vaccines. There have been no major concerns, such as illness, with RH5.1 or Matrix-M.

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.