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Hepatitis EPhase 4NCT02964910

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatitis E
What is being tested?
Recombinant Hepatitis E Vaccine (Escherichia Coli)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
475 participants
Where
1 siteChina
Study dates
Aug 2016to Dec 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged over 30 years old on the day of enrollment
  • Axillary temperature is below than 37.0 ℃.
  • No administration of HEV vaccine before the study
  • Judged as healthy and eligible for vaccination by the investigators through a selfreported 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.
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  • Negative serological markers for hepatitis E
  • ALT < 1.5×ULN
  • No spleen swelling,no cirrhosis and no hepatocellular carcinoma
  • 1. HBsAg(-)

Who cannot join

  • With clinical evidence of malignant tumor
  • History of severe cardio-cerebrovascular disease
  • Administration of hepatotoxicity drugs before or during the study
  • Pregnancy,breast-feeding or plan to be pregnant in 7 months later
  • 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.
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  • 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.
  • 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.
  • Allergic history to any component of this vaccine.
  • Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years.
  • Combining another severe internal medicine disease(such as severe hypertension, cardiopathy,diabetes and hyperthyroidism)
  • Anomal coagulation function or coagulopathy diagnosed by doctor
  • Epilepsy(not including alcohol epilepsy within 3 years prior to abstinence and simple epilepsy that do without curing within 3 years prior to the study )
  • Anomal psychology or mind affecting the individual's ability to obey the study requie
  • 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.

China1 site

  • Rushan Center for Disease Control and Prevention

    Weihai, Shandong

Other trials in China

About this study

Official title: An Open, Pared Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® in the Chronic Hepatitis B Patients on the Clinical Stability .( Aged 30 Years or Over)

This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.

Read the detailed description

This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in the chronic Hepatitis B patients on the clinical stability and aged over 30 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 receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.

Study groups in NCT02964910
Study groupRoleWhat they receive
the chronic Hepatitis B patientsExperimentalParticipants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.
Receives: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)
the healthy volunteerActive comparatorParticipants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.
Receives: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose

    Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.

    Measured: Month 7

  2. Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose

    Measure the level of anti-HEV antibody in serum samples at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.

    Wu/ml：World Health Organization (WHO) units per ml. The WHO standard was used to calibrate the antibody quantitative reference.

    Measured: Month 7

Secondary outcomes (8)

  1. Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose

    ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.

    Measured: Day 0-Month 1

  2. Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose

    ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.

    Measured: Month 6-Month 7

  3. Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose

    ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.

    Measured: Day0-Month 7

  4. Number of Participants Who Experienced Any Adverse Reactions/Events

    Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation.

    Measured: Day 0-Month 7

  5. Number of Participants Who Experienced Solicited Adverse Reactions/Events

    Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination.

    Measured: Day 0-Day 7

  6. Number of Participants Who Experienced Solicited Local Adverse Reactions/Events

    Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination.

    Measured: Day 0-Day 7

  7. Number of Participants Who Experienced Solicited System Adverse Reactions/Events

    Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination.

    Measured: Day 0-Day 7

  8. Number of Participants Who Experienced Unsolicited Adverse Reactions/Events

    Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation.

    Measured: Day 0-Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2017
  4. Study completionDec 2017

Resources

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
475 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964910
Sponsor's protocol ID
PRO-HE-009
Status last verified
Jul 2019
First submitted
9 Nov 2016
Last updated
25 Jul 2019
Data monitoring committee
Yes
Individual data sharing
Yes

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 10 inclusion and 19 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 25 Jul 2019. 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?

Yes. Results are posted in the registry (first posted 25 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose (time frame: Month 7). The study lists 2 primary outcomes in all. 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 NCT02964910.

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 25 Jul 2019.

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