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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hepatitis B vaccine
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring hepatitis B, hepatitis B vaccine, immunogenicity, adults

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

20μg, 0-1-6

60μg, 0-1

60μg, 0-2

Arm Description

117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.

112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.

125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 18, 2014
Last Updated
October 7, 2019
Sponsor
Peking University
Collaborators
Guangxi Center for Disease Control and Prevention, Liuzhou City Center for disease control and prevention, Shenzhen Kangtai Biological Products Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT02203357
Brief Title
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Official Title
A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Guangxi Center for Disease Control and Prevention, Liuzhou City Center for disease control and prevention, Shenzhen Kangtai Biological Products Co., LTD

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
hepatitis B, hepatitis B vaccine, immunogenicity, adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20μg, 0-1-6
Arm Type
Active Comparator
Arm Description
117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
Arm Title
60μg, 0-1
Arm Type
Experimental
Arm Description
112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
Arm Title
60μg, 0-2
Arm Type
Experimental
Arm Description
125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine
Intervention Description
Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
Primary Outcome Measure Information:
Title
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Description
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.
Time Frame
one month after a series vaccination of the regimen
Secondary Outcome Measure Information:
Title
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Description
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.
Time Frame
1-year after the first dose of the regimens
Title
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Description
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.
Time Frame
2-year after the first dose of the regimens
Other Pre-specified Outcome Measures:
Title
Safety of HBV Vaccine Determined by Number of Participants With Adverse Events
Description
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.
Time Frame
0-3 day after the first dose of immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongliao Fang, Dr.
Organizational Affiliation
Guangxi provincial center for desease control and prevention
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hui Zhuang, Dr.
Organizational Affiliation
Peking University Health Science Center
Official's Role
Study Director
Facility Information:
Facility Name
Peking University
City
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26801063
Citation
Wang ZZ, Li MQ, Wang P, Yang ZX, Wei L, Zeng Y, Li YP, Yan L, Liu XE, Zhuang H. Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China. Vaccine. 2016 Feb 17;34(8):1034-9. doi: 10.1016/j.vaccine.2016.01.018. Epub 2016 Jan 19.
Results Reference
derived

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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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