title: G-protein based ELISA as a potency test for rabies vaccines.
abstract: The NIH test is currently used to assess the potency of rabies vaccine, a key criterion for vaccine release. This test is based on mice immunization followed by intracerebral viral challenge. As part of global efforts to reduce animal experimentation and in the framework of the development of Sanofi Pasteur next generation, highly-purified vaccine, produced without any material of human or animal origin, we developed an ELISA as an alternative to the NIH test. This ELISA is based on monoclonal antibodies recognizing specifically the native form of the viral G-protein, the major antigen that induces neutralizing antibody response to rabies virus. We show here that our ELISA is able to distinguish between potent and different types of sub-potent vaccine lots. Satisfactory agreement was observed between the ELISA and the NIH test in the determination of the vaccine titer and their capacity to discern conform from non-conform batches. Our ELISA meets the criteria for a stability-indicating assay and has been successfully used to develop the new generation of rabies vaccine candidates. After an EPAA international pre-collaborative study, this ELISA was selected as the assay of choice for the EDQM collaborative study aimed at replacing the rabies vaccine NIH in vivo potency test.
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Chabaud-Riou
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Nadège
authors.initials: N
authors.lastname: Moreno
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Fabien
authors.initials: F
authors.lastname: Guinchard
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Marie Claire
authors.initials: MC
authors.lastname: Nicolai
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Niogret-Siohan
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Sève
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: catherine.manin@sanofipasteur.com.
authors.forename: Catherine
authors.initials: C
authors.lastname: Manin
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Guinet-Morlot
authors.affiliation: Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Riou
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology; D057134:Antibodies, Neutralizing / Q000276:immunology; D000914:Antibodies, Viral / Q000276:immunology; D000956:Antigens, Viral / Q000276:immunology; D004355:Drug Stability; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D054884:Host-Pathogen Interactions / Q000276:immunology; D006801:Humans; D051379:Mice; D011818:Rabies / Q000276:immunology / Q000821:virology; D011819:Rabies Vaccines / Q000276:immunology* / Q000592:standards; D011820:Rabies virus / Q000276:immunology / Q000502:physiology; D015203:Reproducibility of Results; D014611:Vaccination; D064166:Vaccine Potency; D015164:Vaccines, Inactivated / Q000276:immunology; D014764:Viral Proteins / Q000276:immunology*
chemical_list: D000911:Antibodies, Monoclonal; D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D000956:Antigens, Viral; D011819:Rabies Vaccines; D015164:Vaccines, Inactivated; D014764:Viral Proteins
keywords: ELISA; G-protein; In-process control; NIH test; Rabies vaccine; Release test