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O型和A型口蹄疫疫苗抗原的中试生产及单价疫苗最佳抗原量的测定

Production of Foot-and-Mouth Disease Type O and A Vaccine Antigens on a Pilot Scale and Determination of Optimal Amount of Antigen for Monovalent Vaccines.

作者信息

Kim Jae Young, Lee Ji-Hye, Yang Jong Min, Lee Seo-Yong, Park Sun Young, Jin Jong Sook, Kim Dohyun, Park Jung-Won, Park Jong-Hyeon, Park Sang Hyun, Ko Young-Joon

机构信息

Animal and Plant Quarantine Agency, Gimcheon-si 39660, Republic of Korea.

Department of Research and Development, FVC, Gimcheon-si 39660, Republic of Korea.

出版信息

Vaccines (Basel). 2023 Jun 26;11(7):1156. doi: 10.3390/vaccines11071156.

DOI:10.3390/vaccines11071156
PMID:37514972
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10383391/
Abstract

Foot-and-mouth disease (FMD) is a highly infectious disease affecting cloven-hoofed animals and causes significant economic losses to the livestock industry. The Type O PanAsia-2 (O PA-2) vaccine strain is protective against a wide range of serotype O FMD virus (FMDV) strains in East Asia, and A22 Iraq/24/64 (A22 IRQ) is the most widely used vaccine strain in FMD vaccine antigen banks. The aim of this study was to produce antigens from O PA-2 and A22 IRQ viruses using a 100 L bioreactor and evaluate the protective efficacy of varying antigen concentrations in pigs. More than 2 μg/mL of the antigen was recovered from the O PA-2 and A22 IRQ virus-infected supernatants. Further, inactivation of O PA-2 and A22 IRQ by binary ethyleneimine revealed that the viral titers decreased below 10 TCID/mL within 13 h and 9 h, respectively. The O PA-2 and A22 IRQ vaccines, containing 10 μg and 5 μg of antigen, respectively, provided protection against homologous viruses in pigs. This is the first report demonstrating that the antigens obtained from the pilot-scale production of O PA-2 and A22 IRQ are viable candidate vaccines. These results will pave the way for industrial-scale FMD vaccine production in South Korea.

摘要

口蹄疫(FMD)是一种影响偶蹄动物的高度传染性疾病,会给畜牧业造成重大经济损失。O型泛亚-2(O PA-2)疫苗株可抵御东亚地区多种O型口蹄疫病毒(FMDV)毒株,而A22伊拉克/24/64(A22 IRQ)是FMD疫苗抗原库中使用最广泛的疫苗株。本研究的目的是使用100 L生物反应器生产O PA-2和A22 IRQ病毒的抗原,并评估不同抗原浓度对猪的保护效果。从感染O PA-2和A22 IRQ病毒的上清液中回收的抗原浓度超过2μg/mL。此外,用双乙烯亚胺对O PA-2和A22 IRQ进行灭活处理后发现,病毒滴度分别在13小时和9小时内降至10 TCID/mL以下。分别含有10μg和5μg抗原的O PA-2和A22 IRQ疫苗对猪的同源病毒具有保护作用。这是第一份证明从O PA-2和A22 IRQ中试规模生产获得的抗原是可行候选疫苗的报告。这些结果将为韩国口蹄疫疫苗的工业化生产铺平道路。

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本文引用的文献

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Vet Microbiol. 2021 Jan;252:108928. doi: 10.1016/j.vetmic.2020.108928. Epub 2020 Nov 16.
2
Effect of formaldehyde and binary ethyleneimine (BEI) on the integrity of foot and mouth disease virus capsid.甲醛和双乙烯亚胺(BEI)对口蹄疫病毒衣壳完整性的影响。
Rev Sci Tech. 1989 Jan;8(3):747-764. doi: 10.20506/rst.8.3.425.
3
Emergency Foot-and-Mouth Disease Vaccines A Malaysia 97 and A Iraq 64 Offer Good Protection against Heterologous Challenge with A Variant Serotype A ASIA/G-IX/SEA-97 Lineage Virus.
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Vaccines (Basel). 2020 Feb 10;8(1):80. doi: 10.3390/vaccines8010080.
4
Improved foot-and-mouth disease vaccine with O PanAsia-2 strain protect pigs against O/Jincheon/SKR/2014 originated from South Korea.改进的 O PanAsia-2 株口蹄疫疫苗可预防源自韩国的 O/Jincheon/SKR/2014 对猪的感染。
Vaccine. 2020 Jan 29;38(5):1120-1128. doi: 10.1016/j.vaccine.2019.11.029. Epub 2019 Dec 3.
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A scale-down model of 4000-L cell culture process for inactivated foot-and-mouth disease vaccine production.4000 升细胞培养工艺的缩小模型用于生产口蹄疫灭活疫苗。
Vaccine. 2019 Oct 8;37(43):6380-6389. doi: 10.1016/j.vaccine.2019.09.013. Epub 2019 Sep 10.
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Validation of a high performance liquid chromatography method for quantitation of foot-and-mouth disease virus antigen in vaccines and vaccine manufacturing.验证一种高效液相色谱法,用于定量检测疫苗和疫苗生产中的口蹄疫病毒抗原。
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Vaccine. 2014 Apr 1;32(16):1882-9. doi: 10.1016/j.vaccine.2014.01.067. Epub 2014 Feb 10.