A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults

Study Overview
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Brief Summary
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The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.

Official Title
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A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 20μg, 0-1-6<br>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule. | Biological: Hepatitis B vaccine<br>* Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.<br>|
| Experimental: 60μg, 0-1<br>112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. | Biological: Hepatitis B vaccine<br>* Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.<br>|
| Experimental: 60μg, 0-2<br>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. | Biological: Hepatitis B vaccine<br>* Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B, hepatitis B vaccine, immunogenicity, adults