ACHIEVEMENTS

EMVDA has generated effective integration and coordination of malaria vaccine research activities throughout Europe, whilst maintaining a high standard of scientific excellence.

EMVDA has created a transparent and collaborative infrastructure among its partners. In addition, the project has harmonised and standardised protocols and assays for vaccine candidate evaluation.

EMVDA has made impressive progress in moving a substantial number of vaccine candidates along the development pipeline. The first EMVDA funded vaccine candidates were, MSP1 (AdCh63 and MVA) and AMA1 (AdCh63 and MVA), which commenced development in late 2008 and early 2009, respectively. cGMP manufacture and toxicology studies were successfully completed in early 2009 and early 2010, respectively. The first MSP1 (AdCh63 and MVA) Phase Ia clinical trial was initiated in November 2009, and the first AMA1 (AdCh63 and MVA) Phase Ia clinical trial was initiated in March 2010. The results of the clinical trials will be available by end of 2010.

In October 2009 the EMVDA Consortium selected two additional malaria vaccine candidates. Both have shown promising results in preclinical analysis, and are currently undergoing preclinical development prior to entering into cGMP production and subsequent Phase Ia clinical trials. 

In addition, tremendous efforts have been made to establish standardised assay systems to allow comparative evaluation of vaccine candidates. A large number of vaccine candidates have been successfully evaluated using this platform, providing a body of valuable data. An impressive amount of novel biological and immunological data has been generated from the various vaccine candidates in the individual projects, which is currently being analysed. 

Within the EMVDA framework the current Afro-Immuno-Assay ELISA, as well as T-Cell and functional parasite growth inhibition assays have been successfully improved, and standardisation is ongoing. These assays will be used in assessing immune responses to candidate antigens in relation to protection from clinical malaria in cohort studies conducted in various epidemiological settings.

The EMVDA PhD Programme is linked to the BioMalPar/EVIMalaR PhD Programme, and a cooperation agreement with the European Molecular Biology Laboratory was signed in autumn 2007. Eight students were selected in spring 2008 to receive a PhD EMVDA scholarship, and they commenced their research projects in autumn 2008. The PhD students have progressed well, and presented their work at the EMVDA Annual Conferences in March 2009 and March 2010.

To further strengthen the EMVDA PhD Programme, and increase interaction with other European Commission (EC) funded malaria PhD schemes, the programme will be integrated within the European Malaria Graduate School.

Summary

In conclusion, the EMVDA project has shown that leading European research laboratories can bring innovative ideas to the malaria vaccine candidate pipeline. By federating facilities and exploiting new technologies, the development and testing of vaccine candidates can be accelerated. EMVDA funding has successfully advanced promising vaccine candidates from the laboratory bench into GMP production, and on to Phase Ia clinical trials with impressive efficiency, accelerated timelines in conformity with the highest international standards. EMVDA has strengthened collaboration between European and African research groups, thus supporting efforts to produce an effective and safe malaria vaccine.

Two global consultative processes, the Malaria Vaccine Technology Roadmap, and the Global Malaria Action Plan have both identified the priority need for a second generation highly efficacious malaria vaccine. EMVDA has placed Europe at the forefront of such global efforts.

Considering the value and impact of the EMVDA concept, it is critical that the EC build on current successes to establish a mechanism for ensuring the successful development of malaria vaccines in the future.