What is the purpose of this trial?
Malaria is a major global health problem, with approximately 214 million cases and 438, 000 deaths each year. There is a great need for a safe, effective malaria vaccine as the range of malaria medicines is limited and drug resistance is increasing. Currently there is no approved malaria vaccine.
The purpose of this study is to assess two types of malaria vaccines in different combinations and at different doses. The study will enable us to assess:
We will do this by giving approximately 66 participants a schedule of vaccinations over 2 to 6 months. We will allocate participants to different groups: some of these will only receive vaccinations in order to measure the uimmune responses to these, whereas others will additionally be exposed them to malaria infection by allowing malaria-infected mosquitoes to bite under carefully regulated conditions. We will follow participants closely to observe if and when they develop malaria. If the vaccines provide some protection against malaria, participants will take longer than usual to develop malaria, or will not develop malaria at all. We will also recruit 8 individuals to be control subjects – these participants won’t receive any vaccinations but will be infected with malaria. Control group participants in VAC072 may also serve as infectivity controls in other trials participating in the same malaria challenge experiment carried out by the Jenner institute. Vaccinated volunteers who do not develop malaria infection in the blood after being challenged with malaria the first time may be invited back to be infected with malaria again in a repeat challenge experiment. This would happen approximately 5-12 months after the first challenge. Follow-up after this second challenge will last approximately 3 months. Up to another 8 individuals will be recruited to be control subjects for the repeat challenge. The purpose of this second challenge is to see how long the protection of the investigational malaria vaccine lasts. You do not need to agree to take part in the second challenge in order to take part in this study.
What does the trial involve?
If you are in group 1, 4 and 5 you will receive three vaccines and then attend a series of follow-up visits. If you are in group 2 or 3 you will receive three vaccinations followed by malaria challenge infection. Groups 6 & 7 will receive no vaccinations before undergoing malaria challenge infection. You will be able to choose whether you are vaccinated or not.
Is there any reimbursement for the trial?
If you are in a vaccination only group, you will receive between £655 and £970 depending on number of visits. If you are in a challenge group, you will receive between £2610 and £2700. 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 malaria vaccine and prevent malaria infection and disease in those living in areas where malaria is common and in travellers to those areas. You will also receive information about your general health.
Are there any risks from taking part in the study?
All risks within this study have been well managed provided that you return for follow up. For more details please read the information sheet.
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. However, if you wish to leave after malaria challenge then you must take the treatment course of Riamet (or an agreed alternative) because of the potentially very serious consequences of untreated malaria infection.