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Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation.

Yike Li1, Xiaofen Huang1, Zhigang Zhang1

  • 1State 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, China.

Viruses
|January 23, 2020
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Summary

Hepatitis E virus (HEV) vaccines using virus-like particles (VLPs) are advancing, with a focus on critical quality attributes for effective characterization. Assays are essential for assessing HEV vaccine potency and clinical performance.

Keywords:
antigenic analysisepitope characterizationhepatitis E vaccineserological evaluationvirion-like epitopeswell-characterized vaccines

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Area of Science:

  • * Virology
  • * Immunology
  • * Vaccinology

Background:

  • * Hepatitis E virus (HEV) causes acute hepatitis globally, posing a public health concern in both resource-limited and developed countries.
  • * While HEV was historically associated with poor sanitation, its prevalence in developed regions is increasingly recognized.
  • * Several Hepatitis E virus-like particle (VLP) vaccine candidates are in clinical development, with one approved in China.

Purpose of the Study:

  • * To review the current pipeline and future development of HEV vaccines, emphasizing critical quality attributes.
  • * To highlight the importance of epitope characterization for VLP-based HEV vaccines.
  • * To discuss the role of immunochemical assays and serological evaluations in vaccine development and assessment.

Main Methods:

  • * Review of current Hepatitis E virus (HEV) vaccine candidates and development strategies.
  • * Emphasis on defining critical quality attributes for virus-like particle (VLP) vaccines.
  • * Discussion of epitope-specific immunochemical assays using monoclonal antibodies (mAbs) for HEV vaccine antigen characterization.
  • * Evaluation of serological methods as biomarkers for clinical performance and vaccine efficacy surrogate assays.

Main Results:

  • * Virus-like particle (VLP) based vaccines are a promising approach for Hepatitis E virus (HEV) prevention.
  • * Critical quality attributes, particularly the presence of relevant epitopes on VLP surfaces, are crucial for eliciting functional antibodies.
  • * Epitope characterization through immunochemical assays and in vitro potency assessments are vital for HEV vaccine development.
  • * Serological evaluation methods serve as important biomarkers for assessing clinical performance.

Conclusions:

  • * The development of well-characterized Hepatitis E virus (HEV) vaccines, particularly VLP-based ones, is progressing.
  • * Defining critical quality attributes and employing robust immunochemical and serological assays are essential for successful HEV vaccine development and evaluation.
  • * These methods are critical for ensuring the efficacy and safety of prophylactic vaccines against HEV infection.