The European Network for Harmonisation of Malaria Vaccine Development (EURHAVAC) is an EU-funded Specific Support Action to establish the coordination of public-funded malaria vaccine development in Europe, in cooperation with WHO/IVR. This project 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, this project will address 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 that address the scientific, technical, regulatory and ethical constraints will be addressed.