Hepatitis ENCT05976594
Long-term Effectiveness of a Recombinant Hepatitis E Vaccine
An observational study of Hepatitis E, run by Xiamen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 32 to 82 years
- Conditions the study is for
- Hepatitis E
- What is being tested?
- serology and virology detection of hepatitis E virus
- How many people
- 2,900 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xinjie）
- ALT ≥ 2.5 ULN
- Born between 1941 and 1991
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongtai Center for Disease Control and Prevention
Dongtai, Jiangsu, 224200
Yang Changlin, 0515-85212669, 759106863@qq.com
About this study
Official title: Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study
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.
Read the 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.
- Conditions
- Hepatitis E
- Being tested
- serology and virology detection of hepatitis E virus
- Keywords
- Hepatitis E, Test-Negative Design, Effectiveness, Vaccine, Rat hepatitis E virus infection
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HE group | Subjects who has been diagnosed as HE. Receives: Diagnostic Test: serology and virology detection of hepatitis E virus | |
| Control group | Subjects who didn't meet the diagnosis criteria of HE. Receives: Diagnostic Test: serology and virology detection of hepatitis E virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two months after sampling
Secondary outcomes (1)
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.
Measured: Two months after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start12 Aug 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis EStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Collaborators
- Dongtai Center for Disease Control and Prevention, Dongtai Hospital of Traditional Chinese Medicine, Dongtai People's Hospital
- Responsible party
- Principal investigator, Jun Zhang, Xiamen University
- Investigators
- Zhang Jun, M.D., Study director, National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976594
- Sponsor's protocol ID
- PRO-HE-004-2
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing requires investigator consent
Publications
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.
PubMed 20728932Zhang 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.
PubMed 25738667
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study
- ClinicalTrials.gov ID
- NCT05976594
- Acronym / sponsor ID
- PRO-HE-004-2
- Conditions
- Hepatitis E
- Keywords
- Hepatitis E, Test-Negative Design, Effectiveness, Vaccine, Rat hepatitis E virus infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Collaborators
- Dongtai Center for Disease Control and Prevention, Dongtai Hospital of Traditional Chinese Medicine, Dongtai People's Hospital
- Study start
- 12 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HE group | – | Diagnostic Test: serology and virology detection of hepatitis E virusSubjects who has been diagnosed as HE. |
| Control group | – | Diagnostic Test: serology and virology detection of hepatitis E virusSubjects who didn't meet the diagnosis criteria of HE. |
Who may qualify
- Ages
- 32 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xinjie）
- ALT ≥ 2.5 ULN
- Born between 1941 and 1991
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serology and virology detection of hepatitis E virusSerum 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. | Diagnostic test | Control group, HE group |
Primary outcome
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.
1 secondary outcome
Rate of rat hepatitis E infection
Time frame: Two months after sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 20728932Zhu 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.
- Background: PubMed 25738667Zhang 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.
- Individual participant dataSharing planned: No. Data sharing requires investigator consent
Related trials for Hepatitis E
RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
Hepatitis B, Chronic
RecruitingPhase 2
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
Hepatitis B, Chronic
RecruitingPhase 1
Study of AT-587 in Healthy Subjects
Hepatitis E
Not yet recruiting
Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis
Hepatitis A, Hepatitis E Virus Infection
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Jun, M.D. study director
National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis E, run by Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Jun, PhD (0592-2184110, zhangj@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hepatitis E infection (time frame: Two months after sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05976594, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.