During the first decade of its existence, EVI has successfully developed 24 malaria antigen combinations in 29 vaccine formulations and advanced 15 vaccine candidates into phase Ia clinical trials, three of which have been transferred to partners for further clinical development. One of these vaccine candidates is now in a phase II clinical trial at four sites in sub-Saharan Africa. The phase Ib and IIb clinical trials of this promising malaria vaccine candidate are funded by the European and Developing Countries’ Clinical Trial Partnership (EDCTP) with co-funding from the Medical Research Council (MRC), UK, Bundesministerium für Bildung und Forschung (BMBF), Germany and the Danish International Development Agency (DANIDA), Denmark plus in-kind contributions from various partners. A third vaccine will enter into phase II during 2012 at two sites in sub-Saharan Africa, also funded by EDCTP, with the co-funding from Irish Aid, BMWF, MRC and Sida, and in kind contributions from all the consortium partners.
A Pregnancy Associated Malaria (PAM) collaboration between Institut Pasteur and the University of Copenhagen funded by EMVI in 2003 for a) the validation of a recombinant VAR2-CSA DBL3-X molecule as a component in a vaccine candidate aimed at offering better protection against PAM, and b) production and optimisation and pre-clinical assessment, based on VAR2 CSA is another example of transition to other funding agency after the successful completion of the initial projects in 2007 and 2008.
The funding of further development was continued by the Bill and Melinda Gates Foundation.
EURHAVAC is the first of the many EC funded projects coordinated by EVI to have been successfully concluded with the fulfilment of its main aims to form a collaborative strategy for malaria vaccine development to define, harmonise and standardise the optimal immunological criteria for:
- Malaria antigen selection
- Selection of appropriate production/expression systems
- Selection of the presentation/adjuvant systems
- Define and harmonise the product specifications in relation to the regulatory requirements of European and International guidelines
- Define and harmonise the production criteria in order to ensure the creation of an affordable vaccine
A summary table entitled Assessment Criteria for Evaluation of Malaria Vaccine Concepts prior to Clinical Lot Production: Rationale for choice of antigen is now being widely used.
This project is one of the pillars of another EC funded project, INYVAX, where the working group on standardisation and facilitation of safety data collection in pre-licensure vaccine clinical trials in resource limited countries, has developed a standard section on data safety collection and evaluation for clinical trial protocol, as well as a template Case Report Form.
EVI also actively supports students, via grants for PhD studies, integrated in EVI funded projects, or where PhD scholarships are integrated in EC funded projects.