Integration to speed-up malaria vaccine development Assay standardisation is important for roadmapping vaccine technology. A European initiative standardised protocols and assays to improve the credibility of generated malaria vaccines. Fundamental Research Health © red2000, Thinkstock Over the years, significant effort has been dedicated towards the development of candidate malaria vaccines derived from diverse novel technologies. The efficacy of specific surface parasite molecules as vaccine antigens depends on their ability to induce particular antibodies and immune protection in animals and humans. Individual groups have developed assays that measure the impact of the vaccine on parasite growth and virulence. However, these assays lack consistency and cannot be compared amongst the different groups, reducing the utility of the results. To address the generated scepticism, the EU-funded OPTIMALVAC (Initiative on optimizing malaria vaccine lab assays evaluation) project proposed to develop harmonised assays to facilitate comparison of results. The idea was to generate a battery of assays that could be used by different groups throughout the world for making decisions on vaccine construct development, product characterisation and clinical development plans. The team focused on humoral, functional and cell-mediated immunity assays for consistent, reproducible, and comparable intra- and inter- laboratory data. Through coordinated efforts, researchers assessed different methods, evaluated similarities and key differences, and identified sources of heterogeneity. OPTIMALVAC partners developed and exchanged reference reagents, guidance documents, standard operating protocols and software, which are available on the project website, the European malaria reagent repository and the European vaccine initiative websites. A physical and virtual malaria reference reagent repository was created with 380 Plasmodium falciparum strains and over 50 characterised hybridomas specific for parasite antigens. In addition, they set up robust links between HIV, tuberculosis, cancer and malaria assay harmonisation procedures. Regulatory and ethical guidelines were revisited to ensure that materials and conduct of activities did not breach global regulations. An informed consent template was also developed for patients donating samples. OPTIMALVAC extended its collaboration to include African centres in malaria endemic countries. Overall, by increasing the accuracy and precision of assay data, the OPTIMALVAC deliverables are expected to strengthen vaccine development efforts and improve vaccine efficacy. With malaria remaining a significant health threat worldwide, vaccine discovery efforts require concerted support. Keywords Malaria, vaccine, OPTIMALVAC, standard operating protocol, reagent repository
