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Key points for the development of mouse immunogenicity test as potency assay for acellular pertussis vaccines
M André1, B Poirier, N Bornstein
1Unité de Contrôle des Médicaments Immunologiques, Agence Française de Sécurité Sanitaire des Produits de Santé Directiondes Laboratoires et des Contrôles, 321 avenue Jean Jaurès, Lyon, 69007, France.
Abstract:
According to WHO and the European Pharmacopoeia, the current potency test for acellular pertussis vaccines is a mouse immunogenicity assay assessing consistency of production from batch to batch. The assay compares the batch under control with a reference vaccine of documented clinical efficacy. This study describes and illustrates critical aspects of the assay, based on our experience on a tricomponent vaccine: validation of immunoassay to quantify mouse antibody response, choice of vaccine immunising doses in the three-doses model, treatment of non-responder mice for calculations, establishment of assay validity criteria.