Clinical trial NCT02203357: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: hepatitis B
hepatitis B vaccine
immunogenicity
adults
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Guangxi Center for Disease Control and Prevention
name: Liuzhou City Center for disease control and prevention
name: Shenzhen Kangtai Biological Products Co., LTD
First posted: 2014-07-29
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
timeFrame: one month after a series vaccination of the regimen
Secondary outcomes:
measure: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
timeFrame: 1-year after the first dose of the regimens
measure: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
timeFrame: 2-year after the first dose of the regimens
Other outcomes:
measure: Safety of HBV Vaccine Determined by Number of Participants With Adverse Events
timeFrame: 0-3 day after the first dose of immunization
Locations:
city: Beijing
country: China
facility: Peking University
Study officials:
affiliation: Guangxi provincial center for desease control and prevention
name: Zhongliao Fang, Dr.
role: STUDY_DIRECTOR
affiliation: Peking University Health Science Center
name: Hui Zhuang, Dr.
role: STUDY_DIRECTOR
References:
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.