Hepatitis EPhase 4NCT03365921

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)

A Phase 4 study testing Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. 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 study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis E
What is being tested?: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 siteChina
Study dates: 27 Oct 2018to 16 Jun 2019
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 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. Aged over 18 years old to 50 years old on the day of enrollment 2. Axillary temperature is below than 37.0 ℃. 3.Negative serological markers for hepatitis E 4. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations.
5. Able to understand this study information and willing to comply with all study requirements.
6. 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.
12. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years; 12. Combining another severe internal medicine disease(such as cardiopathy,diabetes and hyperthyroidism) 13. Anormal coagulation function or coagulopathy diagnosed by doctor; 14. 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 ) 15. Anomal psychology or mind affecting the individual's ability to obey the study requirement; 16. 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

Dongtai City Center for Disease Control and Prevention
Dongtai, Jiangsu, 224200

Other trials in China

About this study

Official title: An Randomized, Double-blinded Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® to Evaluate Lot-to-lot Consistency

This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.

Read the detailed description

This study is a mono-center, randomization, double-blind clinical trial in healthy subjects between 18 to 50. Under the premise of full informed consent, 360 subjects that meet the requirement of clinical trial in the age of 18-50 will be divided into 3 groups and injected 3 consecutive batches of Hecolin® separately. The main outcome measures are the immunogenicity evaluation and safety surveillance after inoculation according to prescribed immunization procedure.

Conditions: Hepatitis E
Being tested: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Medical subject headings: Hepatitis E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.Biological
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.

Study groups in NCT03365921
Study group	Role	What they receive
Hepatitis E vaccine lot 1	Experimental	Not described Receives: Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Hepatitis E vaccine lot 2	Experimental	Not described Receives: Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Hepatitis E vaccine lot 3	Experimental	Not described Receives: Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.

What is being measured

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

Seroconversion rate and GMC of anti-HEV IgG at Month 7.
Measure anti-HEV IgG in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.
Measured: 7 months

Secondary outcomes (1)

Adverse reactions/events of all subjects
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 7 months

Timeline

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

27 Oct 201816 Jun 2019

First posted7 Dec 2017
Study start27 Oct 2018
Primary completion16 Jun 2019
Study completion16 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03365921
Sponsor's protocol ID: PRO-HE-010
Status last verified: Apr 2020
First submitted: 1 Dec 2017
Last updated: 7 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
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RecruitingPhase 1
Study of AT-587 in Healthy Subjects
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Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis
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All Hepatitis E trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Randomized, Double-blinded Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® to Evaluate Lot-to-lot Consistency
ClinicalTrials.gov ID: NCT03365921
Acronym / sponsor ID: PRO-HE-010
Conditions: Hepatitis E
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
Collaborators: Jiangsu Province Centers for Disease Control and Prevention
Study start: 27 Oct 2018 (actual)
Primary completion: 16 Jun 2019 (actual)
Study completion: 16 Jun 2019 (actual)
First posted: 7 Dec 2017 (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 study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Hepatitis E vaccine lot 1	Experimental	Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Hepatitis E vaccine lot 2	Experimental	Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Hepatitis E vaccine lot 3	Experimental	Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

1. Aged over 18 years old to 50 years old on the day of enrollment 2. Axillary temperature is below than 37.0 ℃. 3.Negative serological markers for hepatitis E 4. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations.
5. Able to understand this study information and willing to comply with all study requirements.
6. Willing to participate in this study and sign informed consent form.

Key exclusion criteria (11 listed)

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;

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
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.	Biological	Hepatitis E vaccine lot 1, Hepatitis E vaccine lot 2, Hepatitis E vaccine lot 3

Primary outcome

Seroconversion rate and GMC of anti-HEV IgG at Month 7.
Time frame: 7 months
Measure anti-HEV IgG in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.

1 secondary outcome

Adverse reactions/events of all subjects
Time frame: up to 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 7 May 2020.

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
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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
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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.

Yuemei Hu principal investigator

Jiangsu Provincial Center for Disease Prevention and Control

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 7 May 2020. 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?

Seroconversion rate and GMC of anti-HEV IgG at Month 7. (time frame: 7 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 NCT03365921.

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 7 May 2020.