New publication of VAC2VAC - monocyte activation test (MAT)

Animal welfare: optimization of an in vitro test alternative to an animal-based method for the control of vaccine batches.

An in vitro method for vaccine batch release can be a valid alternative to the test cur-rently carried out in animals. In particular, the monocyte activation test (MAT) allows the detection of pyrogens, molecules able to induce unwanted febrile processes.

Development and optimization of this test were carried out by a team of researchers from Istituto Superiore di Sanit? (ISS) thanks to  "VAC2VAC? project. These data have been recently published in ALTEX journal.

?This method is a valid alternative to the pyrogen test currently carried out in rabbits - declares Eliana M. Coccia, researcher of the Immunology Unit in the Department of Infectious Diseases (ISS), head of the research team - and therefore, MAT is in line with the Directive 2010/63/EU on the protection of animals used for scientific pur-poses. In particular, in the MAT, vaccines are directly tested on cultures of human monocytes present in the peripheral blood, which represent the main cells able to detect pyrogens. These cells release factors that induce inflammation such as inter-leukin 6 (IL-6), IL-1 and tumor necrosis factor alpha (TNF-alpha), thus causing fever. Therefore, by detecting their levels, it is possible to establish whether pyrogens are present in the vaccine under testing.?

?In this study, MAT was optimized to evaluate the pyrogenic content of the human vaccine against tick borne encephalitis - continues the expert - but its application can potentially be extended to many other vaccines for human use."

"The added value of this assay - specifies Marilena P. Etna, researcher of the ISS team ? relies on the possibility to detect pyrogens in vaccines intended for humans on a platform based on human cells that have a more accurate sensitivity in respect to rabbits".

"In this context - concludes Eliana M. Coccia - thanks to the experience gained with the development of the MAT assay, ISS becomes one of the few Official European Con-trol Laboratories that are currently able to perform this test thus promoting and actively contributing to the development of alternative strategies to the use of animals for scientific purposes".

This work was carried out in collaboration with Christina von Hunolstein and Andrea Gaggioli of the National Center for Control and Evaluation of Medicines (ISS).

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