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

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ClinicalTrials.gov Identifier: NCT02203357
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : October 3, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
Guangxi Center for Disease Control and Prevention
Liuzhou City Center for disease control and prevention
Shenzhen Kangtai Biological Products Co., LTD
Information provided by (Responsible Party):
Xueen Liu, Peking University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Hepatitis B vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
Study Start Date : March 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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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.
 Biological: Hepatitis B vaccine
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, 0-1
112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
 Biological: Hepatitis B vaccine
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.
 Biological: Hepatitis B vaccine
Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.



Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203357


Locations
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China
Peking University
Beijing, China, 100191
Sponsors and Collaborators
Peking University
Guangxi Center for Disease Control and Prevention
Liuzhou City Center for disease control and prevention
Shenzhen Kangtai Biological Products Co., LTD
Investigators
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Study Director: Zhongliao Fang, Dr. Guangxi provincial center for desease control and prevention
Study Director: Hui Zhuang, Dr. Peking University Health Science Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xueen Liu, Dr., Peking University
ClinicalTrials.gov Identifier: NCT02203357    
Other Study ID Numbers: HepB-2014
First Posted: July 29, 2014    Key Record Dates
Results First Posted: October 3, 2019
Last Update Posted: October 18, 2019
Last Verified: October 2019
Keywords provided by Xueen Liu, Peking University:
hepatitis B
hepatitis B vaccine
immunogenicity
adults
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections