A collaborative study of an alternative in vitro potency assay for the Japanese encephalitis vaccine.
Virus Res
; 223: 190-6, 2016 09 02.
Article
en En
| MEDLINE
| ID: mdl-27497622
ABSTRACT
The use of inactivated Japanese encephalitis (JE) vaccines has been ongoing in East Asia for 40 years. A mouse immunogenicity assay followed by a Plaque Reduction Neutralization (PRN) Test (PRNTest) is currently recommended for each lot release of the vaccine by many national authorities. We developed an alternative in vitro ELISA to determine the E antigen content of the Japanese encephalitis virus to observe the 3Rs strategy. A collaborative study for replacing the in vivo potency assay for the Japanese encephalitis vaccine with the in vitro ELISA assay was confirmed comparability between these two methods. The study demonstrated that an in vitro assay could perform faster and was more convenient than the established in vivo PRNTest. Moreover, this assay had better precision and reproducibility compared with the conventional in vivo assay. Additionally, the content of antigen determined using the in vitro ELISA correlated well with the potency of the in vivo assay. Furthermore, this method allowed discrimination between individual lots. Thus, we propose a progressive switch from the in vivo assay to the in vitro ELISA for JE vaccine quality control.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Ensayo de Inmunoadsorción Enzimática
/
Vacunas contra la Encefalitis Japonesa
/
Virus de la Encefalitis Japonesa (Especie)
/
Potencia de la Vacuna
Tipo de estudio:
Diagnostic_studies
Límite:
Animals
/
Humans
Idioma:
En
Revista:
Virus Res
Asunto de la revista:
VIROLOGIA
Año:
2016
Tipo del documento:
Article