Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）

August 15, 2018 updated by: Jun Zhang

Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years

The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

601

Phase

  • Phase 4

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
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Center for disease control and prevention in Xiamen haicang district

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 and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
  • Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
  • Subjects will reside in the study region in the next 7 months.
  • Free of history of hepatitis E.
  • Can comply with the request of study.
  • Axillary temperature is below 37 degree centigrade.

Exclusion Criteria:

For dose 1:

  • receiving other vaccine or immunoglobulin within two weeks;
  • Having serious 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, genetic defect, HIV or other factors;
  • Congenital malformation, eccyliosis or severe chronic 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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Senior group(over 65 years old)-HE
Anti-HEV IgG seronegative participants over 65 years old were enrolled. 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: Recombinant (E. Coli) Hepatitis E Vaccine
Other Names:
  • Hecolin®
Active Comparator: Younger groups(16-65 years old)
Participants aged 16-65 years old were enrolled. 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: Recombinant (E. Coli) Hepatitis E Vaccine
Other Names:
  • Hecolin®
No Intervention: Senior group(over 65 years old)-Cont
Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: From month 0-7
Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
From month 0-7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti-HEV IgG seropositive rate
Time Frame: at month 7
at month 7
GMT of anti-HEV IgG
Time Frame: 7 month after first vaccination
Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested
7 month after first vaccination

Collaborators and Investigators

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

Sponsor

Jun Zhang

Collaborators

Xiamen Innovax Biotech Co., Ltd
Xiamen Center for Disease Control and Prevention

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

June 1, 2014

Primary Completion (Actual)

December 7, 2015

Study Completion (Actual)

December 7, 2015

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-HE-05

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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