Key points for the development of mouse immunogenicity test as potency assay for acellular pertussis vaccines.
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.
André
M
M
Unité 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.
Poirier
B
B
Bornstein
N
N
Marmonier
D
D
El Zaouk
A
A
Fuchs
F
F
D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood; D001886:Bordetella pertussis / Q000276:immunology; D005260:Female; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D051379:Mice; D010567:Pertussis Vaccine / Q000032:analysis* / Q000276:immunology* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D022282:Vaccines, Acellular / Q000032:analysis / Q000276:immunology / Q000592:standards
D000907:Antibodies, Bacterial; D010567:Pertussis Vaccine; D022282:Vaccines, Acellular