Malaria Clinical Trial
Official title:
Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Virosomal Vaccine PEV3A and FP9-MVA ME-TRAP. A Phase I / IIa Controlled Challenge Trial
The purpose of this study is to test three candidate malaria vaccines in new combinations to assess their efficacy at preventing malaria infection and triggering immune responses against malaria.
Two of the vaccines (‘FP9 ME-TRAP’ and ‘MVA ME-TRAP’) have been designed at the University
of Oxford. The other vaccine (PEV3A) has been designed jointly between the Swiss Tropical
Institute and a Swiss company called Pevion Biotech Ltd. These are new vaccines that have
been given to only a limited number of people before.
We aim to test these vaccines by:
- assessing their ability to prevent malaria infection
- determining how good they are at triggering a detectable immune response against
malaria
- studying their safety further
Volunteers will be given up to six vaccinations over three months and will then be exposed
to malaria infection. We do this by allowing mosquitoes infected with malaria to bite them
under closely regulated conditions and observing if and when they develop blood stage
malaria. If the vaccines provide some protection from malaria infection then either they
will not develop malaria after the bites or the time taken to develop malaria will be
longer. If not all volunteers are protected then we will be able to try and improve our
vaccines by comparing the immune responses of volunteers who are protected to those not
protected.
The information we get from this study may help to prevent malaria infection and disease in
those who live in endemic areas and in travellers. The results of this study will be
published in scientific journals and may be presented at professional meetings.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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