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What is the purpose of this trial?

Malaria is a major global health problem. It is a potentially fatal disease caused by a parasite, which is transmitted to people by mosquitoes. Each year there are more than 200 million cases and over 400,000 deaths worldwide, most of which (61%) occur in children under 5 years old. There is a great need for new ways to reduce the spread of malaria by mosquitoes.

Pfs25-IMX313/Matrix-M1 is a new ‘transmission-blocking vaccine’ for malaria. The vaccine aims to cause the body to produce an immune response, which blocks the malaria parasite developing in the mosquito, so that when the mosquito next bites, it cannot infect another person with malaria. This means that unlike other vaccines, Pfs25-IMX313/Matrix-M1 does not aim to protect the person being vaccinated from disease but instead to reduce risk of infection to other people. In this way, if effective, a transmission-blocking vaccine could stop onward transmission of malaria and bring down the number of cases in the whole population.

This is the first trial to use the Pfs25-IMX313/Matrix-M1 vaccine in humans. 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 volunteers three vaccinations, given at 4-week intervals, doing blood tests and collecting information about any symptoms that occur after vaccination. We plan to recruit a total of 8 volunteers to be vaccinated.

 

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Am I eligible to participate?

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FAQs

What does the trial involve?
Volunteers who take part in this study will be involved for approximately 8 months and attend 16 visits.
Each volunteer will receive three vaccinations, given four weeks apart. All three vaccines are given by injection into the muscle, usually into the upper arm. After each vaccination, we will see volunteers in clinic at regular intervals to assess for side effects and take blood samples to analyse the body’s immune response to the vaccines. Volunteers will also be asked to complete a diary, to record any symptoms experienced after vaccination.

Is there any reimbursement for the trial? 
Yes, you will be reimbursed at set rates (up to £790) for your time, inconvenience and travel. Full details of reimbursement can be found in the trial information sheets.

What are the advantages of taking part?
This study will not benefit you, but by taking part, you will contribute to the knowledge gained from this study, as the information gathered might help in the development of a safe and effective vaccine, to prevent transmission of malaria. At present, there is no approved transmission-blocking vaccine for malaria licensed anywhere in the world. You will also be able to get information about your general health during the pre-enrolment process.

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?
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 decision will not result in any penalty, or loss of benefits to which you are otherwise entitled. 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 full 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.