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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 9, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date August 17, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date December 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • anti-HEV IgG seropositive rate [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine(Hecolin®)
Official Title  ICMJE Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine(Hecolin®) in Seniors Aged Over 65 Years
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis E
Intervention  ICMJE Biological: Recombinant (E. Coli) Hepatitis E Vaccine
Other Name: Hecolin®
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Recombinant (E. Coli) Hepatitis E Vaccine
  • 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.
    Intervention: Biological: Recombinant (E. Coli) Hepatitis E Vaccine
  • 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.
Publications * Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2018)
601
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
600
Actual Study Completion Date  ICMJE December 7, 2015
Actual Primary Completion Date December 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189603
Other Study ID Numbers  ICMJE PRO-HE-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Zhang, Xiamen University
Study Sponsor  ICMJE Jun Zhang
Collaborators  ICMJE
  • Xiamen Innovax Biotech Co., Ltd
  • Xiamen Center for Disease Control and Prevention
Investigators  ICMJE Not Provided
PRS Account Xiamen University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP