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

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.

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