Clinical development of a Pfs48/45-based malaria t.. (REDMAL)
Clinical development of a Pfs48/45-based malaria transmission blocking vaccine
Date du début: 1 mars 2010,
Date de fin: 30 nov. 2014
Malaria vaccines are needed to reduce the unacceptably high burden of disease and death in particular in the lowest income countries. Malaria vaccines aim at interruption of the life cycle of the parasite Plasmodium falciparum by induced immune responses in the humans. Transmission-blocking vaccines (TBMV) specifically aim at an arrest sexual stage development preventing the generation of infectious mosquitoes. TBMVs are the most effective tools for reduction of the spread of malaria in the population. This is indispensible for sustained control, elimination and eventually eradication. Pfs48/45 is the most advanced EU-developed malaria TBMV candidate. PF10C is a subunit of Pfs48/45 that has been produced as R0-PF10C in a 20L fermentor. Immunization with 100% properly folded R0-PF10C induced transmission-blocking activity in 100% of immunized mice.Objectives: 1) Manufacture R0-PF10C at cGMP grade and 2) Prepare for clinical trials with R0-PF10C in Africa.Workplan: R0-PF10C production will be optimized and up-scaled for release of clinical grade batches for human trials. To prepare for clinical testing to Africa, preparation for Phase II will be initiated. A Phase II trial of a malaria TB vaccine will require a specific design. Important transmission parameters will be collected and introduced in a mathematical model to study the possible impact on transmission in the selected study area.Milestones: 1) Batch release R0-PF10C for use in clinical trial; 2) Preparation of field site for phase IIb clinical trial with R0-PF10C vaccine
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