Long-term Effectiveness of a Recombinant Hepatitis E Vaccine

Status Recruiting

Clinical Trial Summary

This test-negative study is designed to evaluate the long-term effectiveness of hepatitis E vaccine (Hecolin®) and to explore the prevalence of rat hepatitis E in Dongtai City.

Clinical Trial Description

In this negative test study, residual clinical serum will be collected from 13 hospitals in Dongtai, if it was from patients born between 1941-1991 from 11 towns in Dongtai, who tested positive for ALT levels higher than 2.5 times the upper limit of normal (ULN). Detection of HEV IgM, IgG, antigen, RNA will be performed to diagnose hepatitis E (HE) in each individual. In addition, HE vaccination history will be collect. All the information above will be used to evaluate the long-term effectiveness of HE vaccine. Based on the study design, virological and serological detection (IgM, IgG, antigen, and RNA) of hepatitis E virus species C (HEV-C) will be performed to analyze the prevalence of rat hepatitis E infection in Dongtai. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05976594
Study type	Observational
Source	Xiamen University
Contact	Zhang Jun, PhD
Phone	0592-2184110
Email	zhangj@xmu.edu.cn
Status	Recruiting
Phase
Start date	August 12, 2023
Completion date	July 1, 2025

View Details

See also
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