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

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ClinicalTrials.gov Identifier: NCT02189603
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Xiamen Center for Disease Control and Prevention
Information provided by (Responsible Party):
Jun Zhang, Xiamen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis E Biological: Recombinant (E. Coli) Hepatitis E Vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years
Study Start Date : June 2014
Actual Primary Completion Date : December 7, 2015
Actual Study Completion Date : December 7, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. anti-HEV IgG seropositive rate [ Time Frame: at month 7 ]
  2. 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189603


Locations
China, Fujian
Center for disease control and prevention in Xiamen haicang district
Xiamen, Fujian, China, 361000
Sponsors and Collaborators
Jun Zhang
Xiamen Innovax Biotech Co., Ltd
Xiamen Center for Disease Control and Prevention
More Information
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Publications:

Responsible Party: Jun Zhang, professor，Xiamen University, Xiamen University
ClinicalTrials.gov Identifier: NCT02189603     History of Changes
Other Study ID Numbers: PRO-HE-05
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

Keywords provided by Jun Zhang, Xiamen University:
hepatitis E
Immunogenicity
vaccine
safety

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis E
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs