Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation

Hepatitis E virus (HEV) infection causes sporadic outbreaks of acute hepatitis worldwide. HEV was previously considered to be restricted to resource-limited countries with poor sanitary conditions, but increasing evidence implies that HEV is also a public health problem in developed countries and re...

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Main Authors: Yike Li, Xiaofen Huang, Zhigang Zhang, Shaowei Li, Jun Zhang, Ningshao Xia, Qinjian Zhao
Format: Article
Language:English
Published: MDPI AG 2020-01-01
Series:Viruses
Subjects:
Online Access:https://www.mdpi.com/1999-4915/12/1/109
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author Yike Li
Xiaofen Huang
Zhigang Zhang
Shaowei Li
Jun Zhang
Ningshao Xia
Qinjian Zhao
author_facet Yike Li
Xiaofen Huang
Zhigang Zhang
Shaowei Li
Jun Zhang
Ningshao Xia
Qinjian Zhao
author_sort Yike Li
collection DOAJ
description Hepatitis E virus (HEV) infection causes sporadic outbreaks of acute hepatitis worldwide. HEV was previously considered to be restricted to resource-limited countries with poor sanitary conditions, but increasing evidence implies that HEV is also a public health problem in developed countries and regions. Fortunately, several vaccine candidates based on virus-like particles (VLPs) have progressed into the clinical development stage, and one of them has been approved in China. This review provides an overview of the current HEV vaccine pipeline and future development with the emphasis on defining the critical quality attributes for the well-characterized vaccines. The presence of clinically relevant epitopes on the VLP surface is critical for eliciting functional antibodies against HEV infection, which is the key to the mechanism of action of the prophylactic vaccines against viral infections. Therefore, the epitope-specific immunochemical assays based on monoclonal antibodies (mAbs) for HEV vaccine antigen are critical methods in the toolbox for epitope characterization and for in vitro potency assessment. Moreover, serological evaluation methods after immunization are also discussed as biomarkers for clinical performance. The vaccine efficacy surrogate assays are critical in the preclinical and clinical stages of VLP-based vaccine development.
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spelling doaj.art-76a19abadb074d60a3770b48c326dc992022-12-21T18:02:01ZengMDPI AGViruses1999-49152020-01-0112110910.3390/v12010109v12010109Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological EvaluationYike Li0Xiaofen Huang1Zhigang Zhang2Shaowei Li3Jun Zhang4Ningshao Xia5Qinjian Zhao6State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, Fujian, ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, Fujian, ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, Fujian, ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, Fujian, ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, Fujian, ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, Fujian, ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, Fujian, ChinaHepatitis E virus (HEV) infection causes sporadic outbreaks of acute hepatitis worldwide. HEV was previously considered to be restricted to resource-limited countries with poor sanitary conditions, but increasing evidence implies that HEV is also a public health problem in developed countries and regions. Fortunately, several vaccine candidates based on virus-like particles (VLPs) have progressed into the clinical development stage, and one of them has been approved in China. This review provides an overview of the current HEV vaccine pipeline and future development with the emphasis on defining the critical quality attributes for the well-characterized vaccines. The presence of clinically relevant epitopes on the VLP surface is critical for eliciting functional antibodies against HEV infection, which is the key to the mechanism of action of the prophylactic vaccines against viral infections. Therefore, the epitope-specific immunochemical assays based on monoclonal antibodies (mAbs) for HEV vaccine antigen are critical methods in the toolbox for epitope characterization and for in vitro potency assessment. Moreover, serological evaluation methods after immunization are also discussed as biomarkers for clinical performance. The vaccine efficacy surrogate assays are critical in the preclinical and clinical stages of VLP-based vaccine development.https://www.mdpi.com/1999-4915/12/1/109antigenic analysisepitope characterizationhepatitis e vaccineserological evaluationvirion-like epitopeswell-characterized vaccines
spellingShingle Yike Li
Xiaofen Huang
Zhigang Zhang
Shaowei Li
Jun Zhang
Ningshao Xia
Qinjian Zhao
Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation
Viruses
antigenic analysis
epitope characterization
hepatitis e vaccine
serological evaluation
virion-like epitopes
well-characterized vaccines
title Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation
title_full Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation
title_fullStr Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation
title_full_unstemmed Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation
title_short Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation
title_sort prophylactic hepatitis e vaccines antigenic analysis and serological evaluation
topic antigenic analysis
epitope characterization
hepatitis e vaccine
serological evaluation
virion-like epitopes
well-characterized vaccines
url https://www.mdpi.com/1999-4915/12/1/109
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AT junzhang prophylactichepatitisevaccinesantigenicanalysisandserologicalevaluation
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