Objective Placental malaria, a special form of malaria targeting pregnant women, causes the death of 200,000 infants and 10,000 pregnant women each year. Placental malaria has no sustainable cure. The overall success criterion of the proposed project is to enable the manufacture of a vaccine, which protects fetus and mother against the adverse effects of malaria during pregnancy. Administered to women before they get pregnant the vaccine should induce antibodies that prevent the binding of malaria parasites in the placenta. Vaccine development is facilitated by the availability of an in vitro assay that predicts clinical immunity. With this proposal, we seek funding to produce the first placental malaria vaccine and perform the first clinical studies in humans. In parallel, we will prepare a field site and a protocol for a phase II study in African women. The partners behind the application have secured funding for ongoing work to down-select the current VAR2CSA lead antigens and to produce GLP batch protein for toxicology studies in animals, prior to the initiation of the work proposed here. Under the proposed FP7 project an SME, ExpreS2ion Biotechnologies will optimize production and purification of the vaccine. ExpreS2ion Biotechnologies operates a unique expression platform and this project will enable the company to expand their business into downstream process development. The academic partners are strong. Researchers at University of Copenhagen, (UCPH) originally discovered the vaccine protein and they have been collaborating with Institut de Recherche pour le Developpement (IRD) and Université d'Abomey-Calavi (UAC) to optimize vaccine antigens and to prepare sites for clinical testing. The European Vaccine Initiative (EVI) will provide product management and coordinate execution of the phase I clinical trial. Thus, this study will provide a product to continue into efficacy studies in Africa, which could be initiated shortly after the end of the project. Fields of science medical and health scienceshealth sciencesinfectious diseasesmalarianatural sciencesbiological sciencesbiochemistrybiomoleculesproteinsmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinesmedical and health sciencesclinical medicineobstetricsmedical and health sciencesclinical medicineembryology Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2012.2.3.2-3 - Prevention and treatment for HIV/AIDS, malaria and tuberculosis Call for proposal FP7-HEALTH-2012-INNOVATION-1 See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator KOBENHAVNS UNIVERSITET Address Norregade 10 1165 Kobenhavn Denmark See on map Region Danmark Hovedstaden Byen København Activity type Higher or Secondary Education Establishments Administrative Contact Tine Mathiesen (Ms.) Links Contact the organisation Opens in new window Website Opens in new window EU contribution € 2 096 620,00 Participants (5) Sort alphabetically Sort by EU Contribution Expand all Collapse all EXPRES2ION BIOTECHNOLOGIES APS Denmark EU contribution € 996 648,00 Address Agern alle 1 2970 Horsholm See on map Region Danmark Hovedstaden Nordsjælland Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Willem Adriaan De Jongh (Dr.) Links Contact the organisation Opens in new window Website Opens in new window INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT France EU contribution € 488 960,00 Address Boulevard de dunkerque 44 cs 90009 13572 Marseille See on map Region Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Bouches-du-Rhône Administrative Contact Jean Albergel (Mr.) Links Contact the organisation Opens in new window Website Opens in new window EUROPEAN VACCINE INITIATIVE EWIV Germany EU contribution € 435 296,58 Address Vossstrasse 2 geb 4040 69115 Heidelberg See on map Region Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis Activity type Research Organisations Administrative Contact Sten Larsen (Mr.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITE D'ABOMEY-CALAVI Benin EU contribution € 904 056,00 Address Campus universitaires d abomey 01 Abomey calavi See on map Activity type Higher or Secondary Education Establishments Administrative Contact Cynel Kahoun (Mr.) Links Contact the organisation Opens in new window Website Opens in new window EBERHARD KARLS UNIVERSITAET TUEBINGEN Germany EU contribution € 1 013 400,00 Address Geschwister-scholl-platz 72074 Tuebingen See on map Region Baden-Württemberg Tübingen Tübingen, Landkreis Activity type Higher or Secondary Education Establishments Administrative Contact Stefanie Bolte (Dr.) Links Contact the organisation Opens in new window Website Opens in new window
