Clinical trial NCT05976594: Long-term Effectiveness of a Recombinant Hepatitis E Vaccine
Official title: Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis E
Keywords: Hepatitis E
Test-Negative Design
Effectiveness
Vaccine
Rat hepatitis E virus infection
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Dongtai Center for Disease Control and Prevention
name: Dongtai Hospital of Traditional Chinese Medicine
name: Dongtai People's Hospital
First posted: 2023-08-04
Enrollment: 2900
Sex: ALL
Minimum age (years): 32
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of hepatitis E infection
timeFrame: Two months after sampling
Secondary outcomes:
measure: Rate of rat hepatitis E infection
timeFrame: Two months after sampling
Other outcomes:
Locations:
city: Dongtai
country: China
facility: Dongtai Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
name: Zhang Jun, M.D.
role: STUDY_DIRECTOR
References:
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.
citation: 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.