Clinical development of a VAR2CSA-based placental .. (PLACMALVAC)
Clinical development of a VAR2CSA-based placental malaria vaccine
Start date: Mar 1, 2013,
End date: Feb 28, 2017
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.
Get Access to the 1st Network for European Cooperation