Tick-borne encephalitis (TBE) virus causes a severe disease that can lead to permanent neurological complications. The whole inactivated TBE vaccine is highly effective, as proven by high seroconversion rates and near eradication of the disease in countries where vaccination programs have been implemented. TBE vaccine potency testing currently requires the use of in vivo methods. As an alternative, a batch-to-batch consistency approach is currently explored which would demonstrate the conformity of a newly produced vaccine batch with a batch with proven in vivo efficacy with respect to a range of in vitro measurable quality parameters.
For the identification of a suitable cellular platform to be used for this method, human cell-based systems, both of primary origin and cell line-derived, were exposed to vaccine formulations of high and low quality. Following stimulation, cell responses were evaluated by assessing the expression of selected genes by qPCR.
It could be shown that the expression of interferon-stimulated genes differed after treatment with non-adjuvanted vaccine batches of different quality in peripheral blood mononuclear cells (PBMCs) and in monocyte-derived dendritic cells, but not in monocyte-free PBMC suspensions nor in cell line-derived immune cells. These results indicate suitable platforms and potential biomarkers for a cell-based assay that, together with other immunochemical analyses, could serve for batch-to-batch assessment of the TBE vaccine, eventually replacing in vivo methods for potency testing.
In vitro assessment of tick-borne encephalitis vaccine: suitable human cell platforms and potential biomarkers
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