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Hepatitis EPhase 4NCT03168412

A Study on the Recombinant Hepatitis E Vaccine (Escherichia Coli) (Accelerated Vaccination Schedule)

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 the recombinant Hepatitis E vaccine (Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults (over 18 years) with accelerated vaccination schedule. 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)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteChina
Study dates
25 May 2017to 28 Nov 2018
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

  • Aged over 18 years old on the day of enrollment, including 18 years old;
  • Axillary temperature is below than 37.0 ℃;
  • Negative serological markers for hepatitis E and liver function are normal or no clinical significance;
  • 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.

Who cannot join

  • Pregnancy,breast-feeding or plan to be pregnant in 7 months;
  • Administration of Hepatitis E Vaccine before the study;
  • Participate 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;
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  • 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, or use 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), liver and kidney disease and other chronic disease history;
  • 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 cardiopathy,diabetes and hyperthyroidism)
  • Anormal 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 requirement;
  • 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

  • Changshan Center for Disease Control and Prevention

    Quzhou, Zhejiang, 324200

Other trials in China

About this study

Official title: A Study on Immunogenicity of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® Using Accelerated Vaccination Schedule in Adults (Aged Over 18 Years)

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 healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days schedule or 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, 7, 21 days.

  • 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 NCT03168412
Study groupRoleWhat they receive
the Accelerated Vaccination Schedule GroupExperimentalParticipants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,7,21 day.
Receives: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)
the Standard Vaccination Schedule GroupActive comparatorParticipants in this arm are aged over 18 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. Anti-HEV antibody of Experimental Group

    Measure anti-HEV antibody in serum samples at 51st day to evaluate the immunogenicity of the Hepatitis E vaccine.

    Measured: up to 2 months

Secondary outcomes (3)

  1. Adverse reactions/events of Experimental Group and Control Group

    Measure solicited local adverse reactions/events within 7 days after each vaccination; Measure solicited systematic adverse reactions/events within 7 days after each vaccination; Measure unsolicited adverse reactions/events within 30 days after vaccination; Measure serious adverse events occurred throughout the study（up to 7 months）.

    Measured: up to 7 months

  2. Anti-HEV antibody of Experimental Group

    Measure anti-HEV antibody in serum samples at 21st day,28st day and month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.

    Measured: up to 7 months

  3. Anti-HEV antibody of Control Group

    Measure anti-HEV antibody in serum samples at month 1,2,7 to evaluate the immunogenicity of the Hepatitis E vaccine.

    Measured: up to 7 months

Timeline

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

  1. First posted30 May 2017
  2. Study start25 May 2017
  3. Primary completion15 Jul 2018
  4. Study completion28 Nov 2018

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168412
Sponsor's protocol ID
PRO-HE-008
Status last verified
Feb 2019
First submitted
14 May 2017
Last updated
21 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen Z, Lin S, Duan J, Luo Y, Wang S, Gan Z, Yi H, Wu T, Huang S, Zhang Q, Lv H. Immunogenicity and safety of an accelerated hepatitis E vaccination schedule in healthy adults: a randomized, controlled, open-label, phase IV trial. Clin Microbiol Infect. 2019 Sep;25(9):1133-1139. doi: 10.1016/j.cmi.2019.01.015. Epub 2019 Jan 31.

    PubMed 30711651

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 16 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 21 Feb 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?

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?

Anti-HEV antibody of Experimental Group (time frame: up to 2 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 NCT03168412, 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 21 Feb 2019.

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