Prophylactic Hepatitis E Vaccines: Antigenic Analysis and Serological Evaluation.

摘要: Hepatitis E virus (HEV) infection causes sporadic outbreaks of acute hepatitis worldwide. HEV was previously considered to be restricted resource-limited countries with poor sanitary conditions, but increasing evidence implies that is also a public health problem in developed and regions. Fortunately, several vaccine candidates based on virus-like particles (VLPs) have progressed into the clinical development stage, one them has been approved China. This review provides an overview current pipeline future emphasis defining critical quality attributes for well-characterized vaccines. The presence clinically relevant epitopes VLP surface eliciting functional antibodies against infection, which key mechanism action prophylactic vaccines viral infections. Therefore, epitope-specific immunochemical assays monoclonal (mAbs) antigen are methods toolbox epitope characterization vitro potency assessment. Moreover, serological evaluation after immunization discussed as biomarkers performance. efficacy surrogate preclinical stages VLP-based development.