Hepatitis EPhase 4NCT02417597
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)
A Phase 4 study testing Recombinant Hepatitis E Vaccine (Escherichia Coli) in people with Hepatitis E, run by Xiamen Innovax Biotech Co., Ltd at 1 site in China.
Trial summary
This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E
- What is being tested?
- Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy people aged over 18 years old on the day of enrollment
- Axillary temperature is below than 37.0 ℃
- Blood pressure is not higher than 160/100 mmHg (with or without any medicine)
- Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
- Able to understand this study information and willing to comply with all study requirements.
- Willing to participate in this study and sign informed consent form.
Who cannot join
- Participated in any other clinical trial during the study period.
- Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
- Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
- Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
- Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
- Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
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- Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
- History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
- Pregnant or breastfeeding
- Allergic history to any component of this vaccine.
- Other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) in Healthy Volunteers Aged Over 65 Years
This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.
- Conditions
- Hepatitis E
- Being tested
- Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Keywords
- hepatitis E
- 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 Hepatitis E Vaccine (Escherichia Coli)Biological
Also called Hecolin®
Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this arm are aged over 65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Receives: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli) |
| Immunogenicity Control Group | Active comparator | Participants in this arm are aged beteen 18-65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. Receives: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli) |
| Safety Control Group | No intervention | Participants in this arm are aged over 65 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions/events
Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study
Measured: up to 10 months
Secondary outcomes (1)
Anti-HEV antibody
Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Innovax Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiamen University, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhiping Chen, Principal investigator, Zhejiang Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417597
- Sponsor's protocol ID
- PRO-HE-006
- Status last verified
- Oct 2015
- First submitted
- 11 Apr 2015
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu XY, Chen ZP, Wang SY, Pan HR, Wang ZF, Zhang QF, Shen LZ, Zheng XP, Yan CF, Lu M, Chen B, Zheng Y, Zhang J, Lv HK, Huang SJ. Safety and immunogenicity of hepatitis E vaccine in elderly people older than 65 years. Vaccine. 2019 Jul 26;37(32):4581-4586. doi: 10.1016/j.vaccine.2019.04.006. Epub 2019 Jun 28.
PubMed 31262585
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) in Healthy Volunteers Aged Over 65 Years
- ClinicalTrials.gov ID
- NCT02417597
- Acronym / sponsor ID
- PRO-HE-006
- Conditions
- Hepatitis E
- Keywords
- hepatitis E
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Xiamen University, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Apr 2015 (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.
This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)Participants in this arm are aged over 65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. |
| Immunogenicity Control Group | Active comparator | Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)Participants in this arm are aged beteen 18-65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month. |
| Safety Control Group | No intervention | –Participants in this arm are aged over 65 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy people aged over 18 years old on the day of enrollment
- Axillary temperature is below than 37.0 ℃
- Blood pressure is not higher than 160/100 mmHg (with or without any medicine)
- Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
- Able to understand this study information and willing to comply with all study requirements.
Key exclusion criteria (11 listed)
- Participated in any other clinical trial during the study period.
- Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
- Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
- Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
- Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
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 Hepatitis E Vaccine (Escherichia Coli)Also: Hecolin®Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month. | Biological | Experimental Group, Immunogenicity Control Group |
Primary outcome
Adverse reactions/events
Time frame: up to 10 months
Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study
1 secondary outcome
Anti-HEV antibody
Time frame: 7 months
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 18 May 2016.
- Derived from this study: PubMed 31262585Yu XY, Chen ZP, Wang SY, Pan HR, Wang ZF, Zhang QF, Shen LZ, Zheng XP, Yan CF, Lu M, Chen B, Zheng Y, Zhang J, Lv HK, Huang SJ. Safety and immunogenicity of hepatitis E vaccine in elderly people older than 65 years. Vaccine. 2019 Jul 26;37(32):4581-4586. doi: 10.1016/j.vaccine.2019.04.006. Epub 2019 Jun 28.
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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.
Zhiping Chen principal investigator
Zhejiang Provincial Center for Disease Control and Prevention
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 Hepatitis E Vaccine (Escherichia Coli) in people with Hepatitis E, run by Xiamen Innovax Biotech Co., Ltd 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 11 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 18 May 2016. 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?
Adverse reactions/events (time frame: up to 10 months). 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 NCT02417597, 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 18 May 2016.