Efficacy of Combined PEV3A Virosomal Vaccine and FP9-MVA ME-TRAP Prime Boost Regimen
|Malaria Malaria, Falciparum||Biological: PEV3A Biological: FP9 ME-TRAP Biological: MVA ME-TRAP||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Vaccine efficacy: The primary outcome is protection against malaria infection in a P. falciparum sporozoite challenge model.
- Immunogenicity - Vaccine immunogenicity assessed by IFN-γ ELISPOT and ELISA for vaccine specific antibodies
- Safety - Vaccine safety assessed by collection of local and systemic adverse events.
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||February 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408668
|Centre for Clinical Vaccinology and Tropical Medicine|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Adrian VS Hill, MA, BM BCh, DPhil, DM||University of Oxford|