Immunogenicity test of tetanus component in adsorbed vaccines by toxin binding inhibition test

Author(s)

Denise Cristina Souza Matos ^[1] ; Rugimar Marcovistz ^[2] ; Pedro Hernan Cabello ^[3] ; Ricardo Amaral Georgini ^[4] ; Dirce Sakauchi ^[5] ; Luciana Leite da Silva ^[6]

Affiliation

^[1] Instituto Butantan. Serviço de Controle de Qualidade - Brasil

^[2] Instituto Butantan. Serviço de Controle de Qualidade - Brasil

^[3] Fiocruz. Departamento de Genética - Brasil

^[4] Instituto Butantan. Serviço de Controle de Qualidade - Brasil

^[5] Instituto Butantan. Serviço de Controle de Qualidade - Brasil

^[6] Instituto Butantan. Serviço de Controle de Qualidade - Brasil

• Document type: Journal article
• Source: Memórias do Instituto Oswaldo Cruz; v. 97, n. 6, p. 909-913, 2002-09-00.

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. (AU)