title: A collaborative study of an alternative in vitro potency assay for the Japanese encephalitis vaccine.
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.
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea; Department of Biology, Chungnam National University, Daejeon 34134, Republic of Korea.
authors: Byung-Chul
authors: BC
authors: Kim
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea; School of Life Sciences and Biotechnology, Korea University, Seoul 02841, Republic of Korea.
authors: Do-Keun
authors: DK
authors: Kim
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea.
authors: Hyung-Jin
authors: HJ
authors: Kim
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea.
authors: Seung-Hwa
authors: SH
authors: Hong
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea.
authors: Yeonhee
authors: Y
authors: Kim
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea.
authors: Jong-Mi
authors: JM
authors: Lim
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea.
authors: JiYoung
authors: J
authors: Hong
authors: Department of Biology, Chungnam National University, Daejeon 34134, Republic of Korea.
authors: Cheol-Hee
authors: CH
authors: Kim
authors: School of Life Sciences and Biotechnology, Korea University, Seoul 02841, Republic of Korea.
authors: Yong-Keun
authors: YK
authors: Park
authors: National Center for Lot Release, Ministry of Food and Drug Safety, Chungcheongbuk-do 28159, Republic of Korea. Electronic address: kimjo70@korea.kr.
authors: Jaeok
authors: J
authors: Kim
mesh_terms: D000818:Animals; D057134:Antibodies, Neutralizing / Q000276:immunology; D000914:Antibodies, Viral / Q000276:immunology; D000956:Antigens, Viral / Q000276:immunology; D004664:Encephalitis Virus, Japanese / Q000276:immunology*; D004672:Encephalitis, Japanese / Q000517:prevention & control; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D022321:Japanese Encephalitis Vaccines / Q000276:immunology*; D009500:Neutralization Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D064166:Vaccine Potency
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D000956:Antigens, Viral; D022321:Japanese Encephalitis Vaccines
keywords: ELISA; Japanese encephalitis vaccines; Plaque reduction neutralization test; in vitro; in vivo