Development of immune assays for CCHF to aid Phase I clinical trials

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Crimean-Congo Haemorrhagic Fever (CCHF) is a widespread disease caused by a tick-borne virus which causes several viral haemorrhagic fever outbreaks, with a case fatality rate of 10-40%. The virus is present in ticks across Africa, Asia, the Middle East and Europe; with recent introduction into Spain associated with human clinical cases. Several different vaccine candidates for CCHF are being progressed through preclinical trials with some starting to enter Phase I clinical trials. This project will develop standardised immune assays for assessing vaccine responses generated after immunisation which meet regulatory standards.To give an overall measurement of immunity, the two main arms of immunity will be measured: the levels of antibodies and the ability of T-cells to respond. This proposal will standardise an antibody-binding assay and develop a multifunction T-cell FluoroSpot assay. The sourcing of high-quality antigens for use in these assays are included within this project. Both assay readouts will be based on automated fluorescence signals ensuring that they are amendable for validation and GxP compliance.Once assays have been designed, they will undergo formal validation with standard operating procedures (SOPs) being developed and compliant to the level required for regulatory approval. These assays and methodology will be applicable across different CCHF vaccine candidates, allowing the harmonisation of outputs and direct comparison between clinical trials. Importantly, they will add to the toolkit for scheduled and future advancement of the multiple CCHF vaccine candidates.