Establishment of the 1st National Reference Standard for Sabin Inactivated Poliomyelitis Vaccine in Korea

Misook Yang; Jung-Min Jung; Naery Lee; Yanghyun Kim; Eunjeong Park; Jong Won Kim; Jin Tae Hong

doi:10.4167/jbv.2021.51.4.189

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2021 Vol.51, Issue 4 Preview Page Next Page

Original Article

Establishment of the 1^st National Reference Standard for Sabin Inactivated Poliomyelitis Vaccine in Korea

31 December 2021. pp. 189-199

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Abstract

In 2019, the first Sabin strain inactivated poliomyelitis vaccine was approved in Korea. It was necessary establishment of national reference standards of that vaccine for consistent quality control and standardization since international standards are provided only in small quantities per year. Therefore, Sabin strain inactivated poliomyelitis vaccine standard candidate was produced in 2019. In this study, we tried to establish the D-antigen content of the candidate standard through collaborate study with five institutions and six laboratories participated in the collaborate research. The candidate standard was set up value of DU/mL with Salk strain International Standard (12/104, NIBSC) and the SDU/mL value was established with the Sabin International Standard (17/160, NIBSC). The D-Ag contents (DU/mL and SDU/mL) derived from each laboratory were calculate using the CombiStat program and analyzed for statistical significance. Earlier this year, the candidate standard was registered as the 1st national reference standard of Sabin strain inactivated poliomyelitis vaccine and the D-Ag contents of the standard was assigned 47, 129, 262 DU/mL and 48, 106, and 193 SDU/mL by each type (Type 1, 2, 3,). Because of established of national standard, it will help consistent quality control and standardization of the Sabin strain inactivated poliomyelitis vaccines.

Keywords

Poliovirus vaccine

Sabin strain

Inactivated vaccine

National reference standard

D-antigen content assay

Quality control

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Information

Publisher :The Korean Society for Microbiology and The Korean Society of Virology
Publisher(Ko) :대한미생물학회‧대한바이러스학회
Journal Title :JOURNAL OF BACTERIOLOGY AND VIROLOGY
Volume : 51
No :4
Pages :189-199
Received Date : 2021-10-06
Revised Date : 2021-12-06
Accepted Date : 2021-12-07
DOI :https://doi.org/10.4167/jbv.2021.51.4.189

JOURNAL OF BACTERIOLOGY AND VIROLOGY ISSN:1598-2467(Print) 2093-0429(Online)

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