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European Network for Harmonisation of Malaria Vaccine Development
Framework programme:
Project number:
EC contribution:
€ 260,000
24 Months
Starting date:
1 December 2006

Keywords: Malaria vaccines, international co-operation, Clinical trials, cGMP production, EMVI, AMANET, EDCTP, WHO


This proposal intends to set-up a coordination of the public-funded malaria vaccine development in Europe in intimate co-ordination with WHO/IVR, in the context of overall global efforts, by establishing a collaborative strategy in malaria vaccine development consisting in formulation of shared strategic plans, and in development of common tools, optimised resources and iterative activities.

This project will stimulate the community of problem-solvers by sharing information, by establishing a correct balance between collaboration and competition, by identifying and prioritising the most critical scientific, technical and regulatory questions. This will constitute a pool of resources which can rapidly be directed to obtain answers to these questions. This project will be the basis for the implementation of common standards for assessing research results and to maximise the sharing and the use of data, resources and knowhow. The strategy for malaria vaccine development is based on two pillars: pharmaceutical development and clinical development.

The overall objective of the proposal is to prepare for the creation of the enabling environment in the field of malaria vaccine development by consolidating the Network of complementary expertise and resources. This SSA will focus on:

  1. Developing and implementing a rationale screening for malaria vaccine antigens, addressing the scientific, technical, regulatory and ethical constraints. This implies to develop reliable assays for in-vitro and animal pre-clinical studies
  2. Design of clinical development strategy for malaria vaccine candidates developed in Europe
  • Definition of the go/no go criteria for entering in phase Ia clinical studies
  • Defining safety evaluation criteria
  • Defining immunological evaluation criteria. This implies to develop the methodology for standardisation of safety and immunological criteria, addressing the scientific, technical, regulatory and ethical constraints.
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