Long-term Effectiveness of a Recombinant Hepatitis E Vaccine

Hepatitis E Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976594
• Other study ID #: PRO-HE-004-2
• Status: Recruiting
• Start date: August 12, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: Xiamen University
• Contact: Zhang Jun, PhD
• Phone: 0592-2184110
• Email: zhangj[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2900
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Years to 82 Years

Eligibility

Inclusion Criteria:

1. From 11 townships(Anfeng?Fuan?Tangyang?Hougang?Liangduo?Qingdong?Shiyan?Shenzao?Wulie?Xuhe?Xin jie)

2. ALT = 2.5 ULN

3. Born between 1941 and 1991

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis E

Intervention

Diagnostic Test:
• serology and virology detection of hepatitis E virus
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.

Locations

Country	Name	City	State
China	Dongtai Center for Disease Control and Prevention	Dongtai	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
Xiamen University	Dongtai Center for Disease Control and Prevention, Dongtai Hospital of Traditional Chinese Medicine, Dongtai People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum In: N Engl J Med. 2015 Apr 9;372(15):1478. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of rat hepatitis E infection	In patients with ALT > 2.5 ULN, rat hepatitis E infection is diagnosed as positive when two of the following virologic or serological tests are positive: (1) IgM anti-HEV-C-; (2) IgG anti-HEV-C- seroconversion or four-fold increase;(3) HEV-C-RNA; (4) HEV-C-antigen.	Two months after sampling