Keywords: malaria vaccine, assays, evaluation, EMVI, OPTIMALVAC, WHO, EVI
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.
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:
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.
European Vaccine Initiative
|Official Address||Other Information|
|1||Pierre Druilhe||Institut Pasteur
|2||Ed Remarque||Biomedical Primate Research Centre
|3||Klavs Berzins||University of Stockholm
|4||David Cavanagh||University of Edinburgh |
|5||Adrian Hill||University of Oxford |
|6||Robert Sauerwein||Radboud University Nijmegen Medical Center
|8||Patrice Dubois||ImmunoVac Consulting
|9||Christian Loucq||Program for Appropriate Technology in Health |
|10||Carlota Dobano||Barcelona Centre for International Health Research
|11||Barry Walker||Health Protection Agency – National Institute for Biological Standards and Control |
|12||Ya Ping Shi||United States Department of Health and Human Services - Centers for Disease Control and Prevention|