Hepatitis EPhase 4NCT02189603
Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
A Phase 4 study testing Recombinant (E. Coli) Hepatitis E Vaccine in people with Hepatitis E, run by Jun Zhang at 1 site in China.
Trial summary
The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E
- What is being tested?
- Recombinant (E. Coli) Hepatitis E Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to 7 Dec 2015
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
- Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
- Subjects will reside in the study region in the next 7 months.
- Free of history of hepatitis E.
- Can comply with the request of study.
- Axillary temperature is below 37 degree centigrade.
Who cannot join
- For dose 1:
- receiving other vaccine or immunoglobulin within two weeks;
- Having serious allergic history to vaccine and medicine
- Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
- Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
- Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, HIV or other factors;
Show all 14Show fewer
- Congenital malformation, eccyliosis or severe chronic disease;
- Fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
- joining other clinical study undergoing;
- women pregnant or in lactation.
- For dose 2 or 3:
- Severe allergy for dose 1 or 2;
- Severe adverse reaction associated with last vaccination;
- New occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
Trial locations and contacts
1 site in 1 country.
China1 site
Center for disease control and prevention in Xiamen haicang district
Xiamen, Fujian, 361000
About this study
Official title: Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years
The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.
- Conditions
- Hepatitis E
- Being tested
- Recombinant (E. Coli) Hepatitis E Vaccine
- Keywords
- hepatitis E, Immunogenicity, vaccine, safety
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant (E. Coli) Hepatitis E VaccineBiological
Also called Hecolin®
| Study group | Role | What they receive |
|---|---|---|
| Senior group(over 65 years old)-HE | Experimental | Anti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. Receives: Biological: Recombinant (E. Coli) Hepatitis E Vaccine |
| Younger groups(16-65 years old) | Active comparator | Participants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. Receives: Biological: Recombinant (E. Coli) Hepatitis E Vaccine |
| Senior group(over 65 years old)-Cont | No intervention | Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
Measured: From month 0-7
Secondary outcomes (2)
anti-HEV IgG seropositive rate
Measured: at month 7
GMT of anti-HEV IgG
Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested
Measured: 7 month after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion7 Dec 2015
- Study completion7 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Xiamen Center for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Jun Zhang, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189603
- Sponsor's protocol ID
- PRO-HE-05
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 20728932
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years
- ClinicalTrials.gov ID
- NCT02189603
- Acronym / sponsor ID
- PRO-HE-05
- Conditions
- Hepatitis E
- Keywords
- hepatitis E, Immunogenicity, vaccine, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Xiamen Center for Disease Control and Prevention
- Study start
- Jun 2014
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 7 Dec 2015 (actual)
- First posted
- 14 Jul 2014 (estimated)
- 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.
The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Senior group(over 65 years old)-HE | Experimental | Biological: Recombinant (E. Coli) Hepatitis E VaccineAnti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
| Younger groups(16-65 years old) | Active comparator | Biological: Recombinant (E. Coli) Hepatitis E VaccineParticipants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
| Senior group(over 65 years old)-Cont | No intervention | –Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
- Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
- Subjects will reside in the study region in the next 7 months.
- Free of history of hepatitis E.
- Can comply with the request of study.
Key exclusion criteria (14 listed)
- receiving other vaccine or immunoglobulin within two weeks;
- Having serious allergic history to vaccine and medicine
- Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
- Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
- Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, HIV or other factors;
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 |
|---|---|---|
| Recombinant (E. Coli) Hepatitis E VaccineAlso: Hecolin® | Biological | Senior group(over 65 years old)-HE, Younger groups(16-65 years old) |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: From month 0-7
Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
2 secondary outcomes
anti-HEV IgG seropositive rate
Time frame: at month 7
GMT of anti-HEV IgG
Time frame: 7 month after first vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant (E. Coli) Hepatitis E Vaccine in people with Hepatitis E, run by Jun Zhang 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 17 Aug 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: From month 0-7). 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 NCT02189603, which also lists 1 linked publication.
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 17 Aug 2018.