Abstract
South Korea has experienced FMD outbreaks almost every year since 2014. Therefore, a novel local vaccine that can cover various topotypes of viruses is required. Two virus strains, O/Boeun/SKR/2017 and A/Yeoncheon/SKR/2017, were cultured up to the pilot scale based on the optimized conditions set up on the flask scale. FMDV particles (146S) of 2 µg/mL or more were obtained from the virus culture supernatant using a 100 L bioreactor. The viruses were fully inactivated using binary ethylenimine within 16 h through two inactivation cycles and mixed with an adjuvant into a bivalent vaccine (types O and A) consisting of 15 µg viruses per strain. The experimental bivalent vaccine showed a broad spectrum of high neutralizing antibody titers against heterologous viruses, including type O Cathay strain and type A Asia topotypes, except for GVII. The 50% protective dose was determined as 12.5 for O/Boeun/SKR/2017 and 15.6 for A/Yeoncheon/SKR/2017. Collectively, we expect that the bivalent vaccine could protect against FMDV types O and A circulating in South Korea and neighboring countries. To our knowledge, this is the first report demonstrating that the vaccine strains could be successfully scaled-up to a 100 L bioreactor, with the determination of its protective efficacy in pigs.
Highlights
Foot-and-mouth disease (FMD) is a highly contagious disease that affects clovenhoof animals, including pigs, cattle, goats, and sheep, causing severe economic damage to the livestock industry [1]
Three distinct topotypes are recognized in Southeast Asia (SEA): O/SEA, O/Middle East-South Asia (ME-SA), and
As test test for scale-up of FMDofvaccine we investigated investigated the optimal conditions for suspension cell culture and virus inoculation
Summary
Foot-and-mouth disease (FMD) is a highly contagious disease that affects clovenhoof animals, including pigs, cattle, goats, and sheep, causing severe economic damage to the livestock industry [1]. The causative agent, FMD virus (FMDV), belongs to the Picornaviridae family. There are seven serotypes of FMDV (O, A, Asia 1, C, SAT-1, SAT-2, and SAT-3), and the rapid mutation rate results in numerous variants in the same serotype with no protective cross-reactivity [2]. The serotype O FMDV consists of 10 topotypes. Three distinct topotypes are recognized in Southeast Asia (SEA): O/SEA, O/Middle East-South Asia (ME-SA), and. The SEA topotype (O/SEA/Mya-98) strain spread to South Korea and
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