NCT05976594

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 12, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

July 19, 2023

Last Update Submit

August 12, 2023

Conditions

Hepatitis E

Keywords

Hepatitis ETest-Negative DesignEffectivenessVaccineRat hepatitis E virus infection

Outcome Measures

Primary Outcomes (1)

  • Rate of hepatitis E infection

    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.

    Two months after sampling

Secondary Outcomes (1)

  • Rate of rat hepatitis E infection

    Two months after sampling

Study Arms (2)

HE group

Subjects who has been diagnosed as HE.

Diagnostic Test: serology and virology detection of hepatitis E virus

Control group

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

Diagnostic Test: serology and virology detection of hepatitis E virus

Interventions

serology and virology detection of hepatitis E virusDIAGNOSTIC_TEST

Serum will be tested for HEV serology and virology, including HEV-IgM, HEV-IgG, HEV-antigen, and HEV-RNA for HEV species A (HEV-A) and HEV species C (HEV-C)，and further HEV genotyping for those positive for HEV-RNA.

Control groupHE group

Eligibility Criteria

Age32 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the designated township who met the criteria of "ALT ≥ 2.5 ULN" and born between 1941 and 1991 will be enrolled in the study.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongtai Center for Disease Control and Prevention

Dongtai, Jiangsu, 224200, China

RECRUITING

Related Publications (2)

  • Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.

    PMID: 20728932BACKGROUND

  • Zhang J, Zhang XF, Huang SJ, Wu T, Hu YM, Wang ZZ, Wang H, Jiang HM, Wang YJ, Yan Q, Guo M, Liu XH, Li JX, Yang CL, Tang Q, Jiang RJ, Pan HR, Li YM, Shih JW, Ng MH, Zhu FC, Xia NS. Long-term efficacy of a hepatitis E vaccine. N Engl J Med. 2015 Mar 5;372(10):914-22. doi: 10.1056/NEJMoa1406011.

    PMID: 25738667BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Clinical residual serum

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Zhang Jun, M.D.

    National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University

    STUDY DIRECTOR

Central Study Contacts

Zhang Jun, PhD

CONTACT

0592-2184110zhangj@xmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 4, 2023

Study Start

August 12, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Data sharing requires investigator consent

Locations

CN(1)