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

Primary Purpose

Hepatitis E

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Recombinant (E. Coli) Hepatitis E Vaccine
Sponsored by
Jun Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis E focused on measuring hepatitis E, Immunogenicity, vaccine, safety

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for disease control and prevention in Xiamen haicang district

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Senior group(over 65 years old)-HE

Younger groups(16-65 years old)

Senior group(over 65 years old)-Cont

Arm Description

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.

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.

Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.

Outcomes

Primary Outcome Measures

Number of Participants with Serious and Non-Serious Adverse Events
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

anti-HEV IgG seropositive rate
GMT of anti-HEV IgG
Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested

Full Information

First Posted
July 9, 2014
Last Updated
August 15, 2018
Sponsor
Jun Zhang
Collaborators
Xiamen Innovax Biotech Co., Ltd, Xiamen Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT02189603
Brief Title
Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
Official Title
Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 7, 2015 (Actual)
Study Completion Date
December 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun Zhang
Collaborators
Xiamen Innovax Biotech Co., Ltd, Xiamen Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis E
Keywords
hepatitis E, Immunogenicity, vaccine, safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Senior group(over 65 years old)-HE
Arm Type
Experimental
Arm Description
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.
Arm Title
Younger groups(16-65 years old)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Senior group(over 65 years old)-Cont
Arm Type
No Intervention
Arm Description
Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.
Intervention Type
Biological
Intervention Name(s)
Recombinant (E. Coli) Hepatitis E Vaccine
Other Intervention Name(s)
Hecolin®
Primary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
Time Frame
From month 0-7
Secondary Outcome Measure Information:
Title
anti-HEV IgG seropositive rate
Time Frame
at month 7
Title
GMT of anti-HEV IgG
Description
Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested
Time Frame
7 month after first vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Center for disease control and prevention in Xiamen haicang district
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20728932
Citation
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.
Results Reference
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Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）

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