Framework programme:

 7

Contract/Grant agreement number:

223126

EC contribution:

1,000,000 €

Duration:

36 months

Funding scheme:

Collaborative research Project: Coordination Action

Starting date:

01/04/2009

Project website:

http://www.optimalvac.eu

 

 

Keywords: malaria vaccine, assays, evaluation, EMVI, OPTIMALVAC, WHO, EVI

Background

A broad-range of candidate malaria vaccines derived from diverse novel technologies have resulted from the multiple approaches being taken by different groups in developing malaria vaccines. The majority of the candidates are recombinant proteins based on complex native antigens found on the surface of the parasite. The vaccine potential of these parasite surface antigens is often supported by epidemiological data, and by the ability to induce measurable antigen-specific antibodies or potential protective responses in animals and later, in humans. In vivo assays such as protection models in mice or non-human primates as well as human sporozoite challenge, provide additional data for some relevant antigens (i.e. pre-erythrocytic antigens).

Individual groups have developed assays within the context of the vaccine discovery efforts, with identification of measurable processes for parasite growth and virulence to test specific antigens. In-house assays are strain, stage and even process specific, and the ability to compare results between different candidates is further limited by diverse methodologies and assay components such as parasites, cells and reagents. The absence of some level of standardisation and harmonisation of practices also makes interpreting the meaning and relevance of vaccine research outcomes complex.

Lack of an enabling environment for comparability of research results generated in different labs could unfortunately lead to scepticism and distrust of the results that in turn generate controversy and uncertainty about the efficacy of the vaccines and rationale of the development pathway. To enable a comparison between the relative merits of different candidate vaccines and approaches in a credible and informed manner, efforts must be made to create an enabling environment by supporting the development of a baseline level of standardisation around key assays that can be utilised, firstly in the evaluation of malaria vaccines, and secondly throughout the development process.

Aims and potential applications

The overall goal of this three year project is to develop harmonised assays to facilitate comparison of results and improve decision making on vaccine construct development, product characterisation, down selection of candidates and/or formulation, and clinical development plans. The specific objectives of the initiative are based on the application of a framework approach to a qualified assay:

1. To apply a uniform strategic approach to the optimisation, harmonisation and qualification of key assays
2. To develop, share and disseminate and implement standard operating procedures (SOP) for the conduct of key assays up to GLP level
3. Develop, share and make available reference preparations and common reagents (sera, antigens, antibodies, cells) for key assays
4. To develop, establish and make available a core set of resources and skills essential for achieving the goal of collaborative action
5. To develop and establish a web based tool for communication amd dissemination of activities and tracking progress and outcomes.

Consistent, reproducible and comparable intra- and inter-lab performance and increased accuracy and precision of assay data will strengthen the quality of the data on vaccine performance and generate greater confidence in the vaccine potential of the candidate.

Coordinator:

ODILE LEROY
European Vaccine Initiative
Heidelberg
Germany
Email: odile.leroy@euvaccine.eu

Partners: