Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine

ABSTRACT As oral poliovirus vaccine (OPV) causes vaccine-associated paralytic poliomyelitis, the polio endgame strategy introduced by the Global Polio Eradication Initiative calls for a phased withdrawal of OPV and an introduction of inactivated poliovirus vaccine (IPV). The introduction of IPV crea...

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Autores principales:	Woo-Jin Shin, Daiki Hara, Francisca Gbormittah, Hana Chang, Byeong S. Chang, Jae U. Jung
Formato:	article
Lenguaje:	EN
Publicado:	American Society for Microbiology 2018
Materias:	Sabin inactivated poliovirus vaccine cold chain thermostable lyophilization D-antigen Microbiology QR1-502
Acceso en línea:	https://doaj.org/article/615253ecf963487895677e0a5720f218
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spelling	oai:doaj.org-article:615253ecf963487895677e0a5720f2182021-11-15T15:52:18ZDevelopment of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine10.1128/mBio.02287-182150-7511https://doaj.org/article/615253ecf963487895677e0a5720f2182018-12-01T00:00:00Zhttps://journals.asm.org/doi/10.1128/mBio.02287-18https://doaj.org/toc/2150-7511ABSTRACT As oral poliovirus vaccine (OPV) causes vaccine-associated paralytic poliomyelitis, the polio endgame strategy introduced by the Global Polio Eradication Initiative calls for a phased withdrawal of OPV and an introduction of inactivated poliovirus vaccine (IPV). The introduction of IPV creates challenges in maintaining the cold chain for vaccine storage and distribution. Recent advances in lyophilization have helped in finding a temperature-stable formulation for multiple vaccines; however, poliovirus vaccines have yet to capture a stable, safe formula for lyophilization. In addition, efficient in vitro methods for antigen measurement are needed for screening stable vaccine formulations. Here, we report size exclusion high-performance liquid chromatography (SE-HPLC) as a reliable means to identify the leading lyophilized formulation to generate thermostable Sabin inactivated poliovirus vaccine (sIPV). High-throughput screening and SE-HPLC determined the leading formulation, resulting in 95% D-antigen recovery and low residual moisture content of sIPV following lyophilization. Furthermore, the lyophilized sIPV remained stable after 4 weeks of incubation at ambient temperature and induced strong neutralizing antibodies and full protection of poliovirus receptor transgenic mice against the in vivo challenge of wild-type poliovirus. Overall, this report describes a novel means for the high-throughput evaluation of sIPV antigenicity and a thermostable lyophilized sIPV with in vivo vaccine potency. IMPORTANCE Poliomyelitis is a highly contagious disease caused by the poliovirus. While the live attenuated OPV has been the vaccine of choice, a major concern is its ability to revert to a form that can cause paralysis, so-called vaccine-associated paralytic poliomyelitis. Therefore, the new endgame strategy of the Global Polio Eradication Initiative includes the introduction of an IPV. However, the feasibility of the use of current IPV formulations in developing countries is limited, because IPV is insufficiently stable to be purified, transported, and stored under unrefrigerated conditions. We successfully designed the sIPV for use in the dry state that maintains the full vaccine potency in animal models after incubation at ambient temperature. This report provides, for the first time, candidate formulations of sIPV that are stable at elevated temperatures.Woo-Jin ShinDaiki HaraFrancisca GbormittahHana ChangByeong S. ChangJae U. JungAmerican Society for MicrobiologyarticleSabin inactivated poliovirus vaccinecold chainthermostablelyophilizationD-antigenMicrobiologyQR1-502ENmBio, Vol 9, Iss 6 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Sabin inactivated poliovirus vaccine cold chain thermostable lyophilization D-antigen Microbiology QR1-502
spellingShingle	Sabin inactivated poliovirus vaccine cold chain thermostable lyophilization D-antigen Microbiology QR1-502 Woo-Jin Shin Daiki Hara Francisca Gbormittah Hana Chang Byeong S. Chang Jae U. Jung Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine
description	ABSTRACT As oral poliovirus vaccine (OPV) causes vaccine-associated paralytic poliomyelitis, the polio endgame strategy introduced by the Global Polio Eradication Initiative calls for a phased withdrawal of OPV and an introduction of inactivated poliovirus vaccine (IPV). The introduction of IPV creates challenges in maintaining the cold chain for vaccine storage and distribution. Recent advances in lyophilization have helped in finding a temperature-stable formulation for multiple vaccines; however, poliovirus vaccines have yet to capture a stable, safe formula for lyophilization. In addition, efficient in vitro methods for antigen measurement are needed for screening stable vaccine formulations. Here, we report size exclusion high-performance liquid chromatography (SE-HPLC) as a reliable means to identify the leading lyophilized formulation to generate thermostable Sabin inactivated poliovirus vaccine (sIPV). High-throughput screening and SE-HPLC determined the leading formulation, resulting in 95% D-antigen recovery and low residual moisture content of sIPV following lyophilization. Furthermore, the lyophilized sIPV remained stable after 4 weeks of incubation at ambient temperature and induced strong neutralizing antibodies and full protection of poliovirus receptor transgenic mice against the in vivo challenge of wild-type poliovirus. Overall, this report describes a novel means for the high-throughput evaluation of sIPV antigenicity and a thermostable lyophilized sIPV with in vivo vaccine potency. IMPORTANCE Poliomyelitis is a highly contagious disease caused by the poliovirus. While the live attenuated OPV has been the vaccine of choice, a major concern is its ability to revert to a form that can cause paralysis, so-called vaccine-associated paralytic poliomyelitis. Therefore, the new endgame strategy of the Global Polio Eradication Initiative includes the introduction of an IPV. However, the feasibility of the use of current IPV formulations in developing countries is limited, because IPV is insufficiently stable to be purified, transported, and stored under unrefrigerated conditions. We successfully designed the sIPV for use in the dry state that maintains the full vaccine potency in animal models after incubation at ambient temperature. This report provides, for the first time, candidate formulations of sIPV that are stable at elevated temperatures.
format	article
author	Woo-Jin Shin Daiki Hara Francisca Gbormittah Hana Chang Byeong S. Chang Jae U. Jung
author_facet	Woo-Jin Shin Daiki Hara Francisca Gbormittah Hana Chang Byeong S. Chang Jae U. Jung
author_sort	Woo-Jin Shin
title	Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine
title_short	Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine
title_full	Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine
title_fullStr	Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine
title_full_unstemmed	Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine
title_sort	development of thermostable lyophilized sabin inactivated poliovirus vaccine
publisher	American Society for Microbiology
publishDate	2018
url	https://doaj.org/article/615253ecf963487895677e0a5720f218
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Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine

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