Clinical Trial of Recombinant Hepatitis E Vaccine

July 9, 2020 updated by: Jun Zhang, Xiamen University

A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine

The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.

The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine.

The initial study is planed to be ended on month 19 and the results were analysed and used for registration purpose. The extended study will be continued to assess the long-term efficacy, immunogenicity and safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were randomly allocated into two groups, one received Hepatitis E vaccine and the other received hepatitis B vaccine. The study was carried out with two stages. In the first stage (phase 3a), 2 645 subjects was enrolled and actively monitored for solicited adverse events for 1 month after each injection. Serum samples from all the subjects were collected on day 0, 7m, 13m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. In the second stage (phase 3b), another 109 959 subjects was enrolled and monitored for solicited adverse events for 1 month after each injection. Serum samples from 9764 subjects among the phase 3b participants were collected on day 0, 7m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. Serious adverse events during the trial were followed up.

Suspected hepatitis cases were identified through an established active hepatitis surveillance system. The sentinels of the system comprised all the healthcare facilities in the field. Suspected hepatitis was defined as when patients presented with systemic symptoms such as fatigue and/or loss of appetite for more than 3 days with alanine aminotransferase (ALT) exceeding 2.5 fold upper limit of normal range (ULN). Paired sera were obtained from these patients at the time of presentation and 2-6 weeks later. Sera were tested for the HEV antibodies and HEV-RNA.

Study Type

Interventional

Enrollment (Actual)

112604

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Dongtai, Jiangsu, China, 224200
        • Dongtai Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
  • Subjects will reside in the study region in the next 19 months.
  • Free of history of hepatitis B or hepatitis E.
  • Can comply with the request of study.
  • Axillary temperature is below 37 degree centigrade.

Exclusion Criteria:

For dose 1:

  • Having other vaccine or immunoglobulin within two weeks;
  • Having 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(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), HIV or other factors;
  • congenital malformation, eccyliosis or severe chronic disease(e.g. Down Syndrome, diabetes, sickle cell anemia or mental 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hepatitis E vaccine
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.
Biological: hepatitis E vaccine
Intramuscularly given at 0, 1, 6m for three doses.
Other Names:
  • Hecolin
PLACEBO_COMPARATOR: HBV vaccine
Hepatitis B vaccine, containing 5mcg of HBsAg recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
Biological: Hepatitis B vaccine
Intramuscularly given at 0, 1, 6m for three doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of confirmed hepatitis E cases
Time Frame: One year since one month post the third injection
One year since one month post the third injection

Secondary Outcome Measures

Outcome Measure
Time Frame
IgG anti-HEV seroconversion rate
Time Frame: On one month post the third injection
On one month post the third injection
Persistency of IgG anti-HEV
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen University

Collaborators

Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
National Institute of Diagnostics and Vaccine Development in infectious disease
Jiangsu Provincial Center for Disease Control and Prevention

Investigators

  • Study Director: Jun Zhang, M.D., National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
  • Principal Investigator: Feng-Cai Zhu, M.D., Jiangsu Provincial Center for Disease Control and Prevention, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (ESTIMATE)

November 17, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro-HE-003
  • 2006AA02A209 (OTHER_GRANT: 863 Program of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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