The European Network for Harmonisation of Malaria Vaccine Development (EURHAVAC)

The two and a half year project, coordinated by EMVI, started in 2006 with a budget of €259 934.

The project aimed at establishing the coordination of public-funded malaria vaccine development in Europe, in cooperation with WHO/IVR, and involves the formation of 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

And to:

·           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.

Additionally, the project has addressed the design of a clinical development strategy for malaria vaccine candidates developed in Europe including:

·           Definition of the go/no go criteria for entering phase 1a clinical studies.

·           Definition of safety evaluation criteria.

·           Definition of immunological evaluation criteria.

In tandem, the development of methodologies for standardisation of safety and immunological criteria related to scientific, technical, regulatory and ethical constraints have been addressed via three workshops held in collaboration with EC and WHO/IVR.