Back to resultsA Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
Primary Purpose
Hepatitis E, Hepatitis B
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
HEV vaccine
HBV vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis E
Eligibility Criteria
Inclusion Criteria:
- Healthy people aged over 18 years old on the day of enrollment
- Negative in HBsAg,HBsAb and HBcAb.
- Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations.
- Able to understand this study information and willing to comply with all study requirements.
- Willing to participate in this study and sign informed consent form.
Exclusion Criteria:
- Pregnant or breastfeeding or planning on getting pregnant in the future 7 months
- Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period
- Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, exceptlocal treatment.
- Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
- Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
- Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
- Plan to participate in any other clinical trial during the study period
- Administration of HEV vaccine before the study.
- Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor,or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
- History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
Sites / Locations
- Beijing Chaoyang District CDC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
HEV vaccine and HBV vaccine Co-administration group
HEV vaccine control group
HBV vaccine control group
Arm Description
Outcomes
Primary Outcome Measures
Adverse reactions/events
Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study
Secondary Outcome Measures
Immunogenicity
Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine. And measure the HBsAb in serum samples at 7 month to evaluate the immunogenicity of Hepatitis B vaccine.
Full Information
NCT ID
NCT02584543
First Posted
October 21, 2015
Last Updated
December 1, 2017
Sponsor
Xiamen Innovax Biotech Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02584543
Brief Title
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
Official Title
Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) Coadministration With Recombinant Hepatitis B Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
August 25, 2016 (Actual)
Study Completion Date
August 25, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiamen Innovax Biotech Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1 and months 1 and 6.
Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis E, Hepatitis B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
602 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEV vaccine and HBV vaccine Co-administration group
Arm Type
Experimental
Arm Title
HEV vaccine control group
Arm Type
Active Comparator
Arm Title
HBV vaccine control group
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
HEV vaccine
Intervention Type
Biological
Intervention Name(s)
HBV vaccine
Primary Outcome Measure Information:
Title
Adverse reactions/events
Description
Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine. And measure the HBsAb in serum samples at 7 month to evaluate the immunogenicity of Hepatitis B vaccine.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy people aged over 18 years old on the day of enrollment
Negative in HBsAg,HBsAb and HBcAb.
Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations.
Able to understand this study information and willing to comply with all study requirements.
Willing to participate in this study and sign informed consent form.
Exclusion Criteria:
Pregnant or breastfeeding or planning on getting pregnant in the future 7 months
Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period
Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, exceptlocal treatment.
Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
Plan to participate in any other clinical trial during the study period
Administration of HEV vaccine before the study.
Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor,or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Zhang
Organizational Affiliation
Beijing Chaoyang District CDC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang District CDC
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
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