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
1 other identifier
interventional
353
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 18, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
October 3, 2019
CompletedOctober 18, 2019
October 1, 2019
2.3 years
July 18, 2014
March 20, 2019
October 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
1-year after the first dose of the regimens
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
2-year after the first dose of the regimens
Other Outcomes (1)
Safety of HBV Vaccine Determined by Number of Participants With Adverse Events
0-3 day after the first dose of immunization
Study Arms (3)
20μg, 0-1-6
ACTIVE COMPARATOR117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
60μg, 0-1
EXPERIMENTAL112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
60μg, 0-2
EXPERIMENTAL125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
Interventions
Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University
Beijing, 100191, China
Related Publications (1)
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.
PMID: 26801063DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hui Zhuang
- Organization
- Peking University Health Science Center
Study Officials
- STUDY DIRECTOR
Zhongliao Fang, Dr.
Guangxi provincial center for desease control and prevention
- STUDY DIRECTOR
Hui Zhuang, Dr.
Peking University Health Science Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
July 18, 2014
First Posted
July 29, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
October 18, 2019
Results First Posted
October 3, 2019
Record last verified: 2019-10