Harmonisation

Several aspects of Research and Development into vaccines for diseases of poverty are hampered because organisations work independently, and with different approaches and technologies. An example, is the often highly specific and localised use of assays to evaluate candidate vaccine efficacy. This undermines confidence when comparisons of efficacy are made between vaccine candidates from different organisations.

EVI’s work in harmonisation of vaccine assays seeks to develop a level of standardisation for several key assays, through agreement on standardised lab procedures, preparations, and reagents, and through promoting their uptake and use.

Similar problems beset tests that compare and select different adjuvants, which are important to enhance vaccine immune response. EVI is also working to address these issues.

An important achievement of harmonisation activities under the EMVDA project has been the establishment of a Reference Reagent Repository (www.malariaresearch.eu)

EVI has been instrumental in the harmonisation of the clinical development plan including the immunoassays used to assess placental malaria vaccine candidates. This will allow taking an informed decision on the further development of these vaccines in a time- and cost –effective way. The outcome of the two workshops has been published in Malaria Journal in 2016 by Chêne et al., “Clinical development of placental malaria vaccines and immunoassays harmonization: a workshop report”.