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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203357
• Other study ID #: HepB-2014
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2019
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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.

Locations

Country	Name	City	State
China	Peking University	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University	Guangxi Center for Disease Control and Prevention, Liuzhou City Center for disease control and prevention, Shenzhen Kangtai Biological Products Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of HBV Vaccine Determined by Number of Participants With Adverse Events	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.	0-3 day after the first dose of immunization
Primary	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	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
Secondary	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