- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203357
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Beijing, China, 100191
- Peking University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
- Written informed consent will be obtained from each subject before the serum screening of HBV markers
- Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
- Have never been immunized with HBV vaccine before
Exclusion Criteria:
- Subject has a medical history of allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Autoimmune disease or immunodeficiency
- Women with pregnant
- Bleeding disorder diagnosed by a doctor
- Chronic diseases: hepatitis, tumor, tuberculosis,et.al
- Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
- Subjects had a medical history of serious adverse reactions to vaccines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 20μg, 0-1-6
117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
|
Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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Experimental: 60μg, 0-1
112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
|
Experimental: 60μg, 0-2
125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Time Frame: one month after a series vaccination of the regimen
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. |
one month after a series vaccination of the regimen
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Time Frame: 1-year after the first dose of the regimens
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs will be compared among the three vaccine groups. |
1-year after the first dose of the regimens
|
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Time Frame: 2-year after the first dose of the regimens
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years. |
2-year after the first dose of the regimens
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of HBV Vaccine Determined by Number of Participants With Adverse Events
Time Frame: 0-3 day after the first dose of immunization
|
Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days.
Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.
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0-3 day after the first dose of immunization
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Zhongliao Fang, Dr., Guangxi provincial center for desease control and prevention
- Study Director: Hui Zhuang, Dr., Peking University Health Science Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HepB-2014
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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