Long-term Effectiveness of a Recombinant Hepatitis E Vaccine

Xiamen University

Status: Enrolling

Conditions: Hepatitis E

Treatments: Diagnostic Test: serology and virology detection of hepatitis E virus

Study type: Observational

Funder types: Other

Identifiers

NCT05976594

PRO-HE-004-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,900 estimated patients

Sex: All

Ages: 32 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xinjie）
2. ALT ≥ 2.5 ULN
3. Born between 1941 and 1991

Trial design

2,900 participants in 2 patient groups

HE group

Description:

Subjects who has been diagnosed as HE.

Treatment:

Diagnostic Test: serology and virology detection of hepatitis E virus

Control group

Description:

Subjects who didn't meet the diagnosis criteria of HE.

Treatment:

Diagnostic Test: serology and virology detection of hepatitis E virus