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Clinical Trials/NCT05976594
NCT05976594RecruitingNot Applicable

Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study

Xiamen University1 site in 1 country2,900 target enrollmentStarted: August 12, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,900
Locations
1
Primary Endpoint
Rate of hepatitis E infection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed 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

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
32 Years to 82 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of hepatitis E infection

Time Frame: Two months after sampling

In patients with ALT \> 2.5 ULN, HEV infection is diagnosed as positive when two of the following indicators are positive: (1) HEV-IgM; (2) Seroconversion or four-fold increase of HEV-IgG；(3) HEV-RNA; (4) HEV-antigen.

Secondary Outcomes

  • Rate of rat hepatitis E infection(Two months after sampling)

Investigators

Sponsor
Xiamen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jun Zhang

professor

Xiamen University

Study Sites (1)

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Long-term Effectiveness of a Recombinant... | Clinical Trial