Vaccines based on generalised modules for membrane antigens (GMMA)-comprise the outer membrane from genetically modified Gram-negative bacteria, containing different compounds including pyrogenic substances which can induce fever. Therefore, controlling their pyrogenic properties is necessary.
In this study, the adaptation of the monocyte activation test (MAT) for monitoring the pyrogenicity of Shigella GMMA-based vaccines is reported. Peripheral blood mononuclear cells (PBMC) derived from human blood samples were used. The cells were incubated with either the vaccine product or with the basis material used for vaccine production. Afterwards, the concentration of the cytokine interleukin-6 was quantified from the cell culture supernatant
The results show that the MAT can be used for testing of pyrogenicity of GMMA-based vaccine products and that the basis material used for the production of the vaccines is a promising reference material for the safety testing of the corresponding vaccine.
Development of a monocyte activation test as an alternative to the rabbit pyrogen test for mono- and multi-component Shigella GMMA-based vaccines
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