title: A relevant in vitro ELISA test in alternative to the in vivo NIH test for human rabies vaccine batch release.
abstract: To assess the quality of vaccine batches before release, international regulation requires the control of potency of each lot of human rabies vaccines by the in vivo NIH challenge test. Meanwhile, the 3Rs strategy for animal testing encourages the replacement of the in vivo potency test by an in vitro assay. Consequently, since more than 10 years, an ELISA method has been implemented by ANSM in parallel to the NIH test for rabies vaccines lots. It consists in the evaluation of the glycoprotein content using a monoclonal antibody recognizing the trimeric native form of the glycoprotein. This ELISA method is able 1) to monitor the consistency of production with a similar profile than the NIH; 2) to detect a low quantity of glycoprotein in vaccines and 3) to agree with the manufacturer's NIH results by declaring a non compliant batch. This ELISA which characterizes the immunogenic form of the glycoprotein formulated in vaccines seems to be relevant to replace the NIH test and is a promising candidate to be standardized by a collaborative study.
authors.affiliation: Agence Nationale de Sécurité du Médicament et des Produits de Santé Department, Control Directorate, Batch Release and Marketing Surveillance of Biological Products Department, 321 avenue Jean Jaurès, F-69007 Lyon, France.
authors.forename: Richard
authors.initials: R
authors.lastname: Gibert
authors.forename: Monique
authors.initials: M
authors.lastname: Alberti
authors.forename: Bertrand
authors.initials: B
authors.lastname: Poirier
authors.forename: Corinne
authors.initials: C
authors.lastname: Jallet
authors.forename: Noël
authors.initials: N
authors.lastname: Tordo
authors.forename: Sylvie
authors.initials: S
authors.lastname: Morgeaux
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006023:Glycoproteins / Q000032:analysis; D006801:Humans; D011819:Rabies Vaccines / Q000737:chemistry / Q000276:immunology*; D064166:Vaccine Potency
chemical_list: D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral; D006023:Glycoproteins; D011819:Rabies Vaccines
keywords: 3Rs; D1 monoclonal antibody; ELISA method; Human rabies vaccine control; In vitro alternative method; NIH test; Native trimeric form of glycoprotein