Initiative on Optimizing Malaria Vaccine Lab Assays Evaluation
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. Vaccine potential of these parasite surface antigens is often supported by epidemiological data, and by the ability to induce specific antibodies or potential protective responses in animals and later, in humans. 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 harmonization 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 of the results that in turn generate uncertainty about the efficacy of the vaccines and rationale of the development pathway.
To compare the relative merits of different candidate vaccines and approaches in a credible and informed manner, efforts must be made to create this enabling environment by supporting the development of a baseline level of standardization around key assays that can be utilized a) in the evaluation of malaria vaccines, and b) throughout the Development process. 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.
STATENS SERUM INSTITUT (DK)
Health
FP7 Project with U.S. partner