title: Immunogenicity test of tetanus component in adsorbed vaccines by toxin binding inhibition test.
abstract: Samples from 20 lots of diphtheria-tetanus (adult use dT) vaccine and from 20 lots of diphtheria-tetanus-pertussis (DTP) vaccine were used to standardize and validate the in vitro toxin binding inhibition (ToBI) test for the immunogenicity test of the tetanus component. The levels of tetanus antitoxin obtained by ToBI test were compared to those obtained using the toxin neutralization (TN) test in mice routinely employed to perform the quality control of the tetanus component in adsorbed vaccines. The results ranged from 1.8 to 3.5 IU/ml for dT and 2 to 4 IU/ml for DTP by ToBI test and 1.4 to 3 IU/ml for dT and 1.8 to 3.5 IU/ml for DTP by TN in mice. These results were significantly correlated. From this study, it is concluded that the ToBI test is an alternative to the in vivo neutralization procedure in the immunogenicity test of the tetanus component in adsorbed vaccines. A substantial refinement and a reduction in use of animals can be achieved.
authors.affiliation: Serviço de Controle de Qualidade, Instituto Butantan, São Paulo, SP, 05503-900, Brasil.
authors.forename: Denise Cristina
authors.initials: DC
authors.lastname: Souza Matos
authors.forename: Rugimar
authors.initials: R
authors.lastname: Marcovistz
authors.forename: Pedro Hernan
authors.initials: PH
authors.lastname: Cabello
authors.forename: Ricardo Amaral
authors.initials: RA
authors.lastname: Georgini
authors.forename: Dirce
authors.initials: D
authors.lastname: Sakauchi
authors.forename: Luciana Leite
authors.initials: LL
authors.lastname: da Silva
mesh_terms: D000818:Animals; D004168:Diphtheria Toxoid; D022422:Diphtheria-Tetanus Vaccine / Q000276:immunology*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology*; D006168:Guinea Pigs; D051379:Mice; D008807:Mice, Inbred BALB C; D009500:Neutralization Tests; D011786:Quality Control; D013743:Tetanus Antitoxin / Q000097:blood / Q000276:immunology*; D013744:Tetanus Toxin; D013745:Tetanus Toxoid
chemical_list: D004168:Diphtheria Toxoid; D022422:Diphtheria-Tetanus Vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D013743:Tetanus Antitoxin; D013744:Tetanus Toxin; D013745:Tetanus Toxoid