The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines

Exclusion Criteria

• •Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:
• •Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
• •Family history of seizures or progressive neurological disease
• •Family history of congenital or hereditary immunodeficiency
• •Women of pregnancy, lactation or about to be pregnant in 60 days
• •Autoimmune disease or immunodeficiency
• •Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
• •Any prior administration of administration of immunoglobulins
• •Filter period: The subjects to receive second or/and third 10mcg recombinant hepatitis B vaccines:
• •Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
• •Serious adverse reactions to vaccines
• •Active infections
• •Subjects who want to quit the study
• •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
• •Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:
• •Qualitative test of Anti-HBs, HBsAg or Anti-HBc on serum is positive
• •Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
• •Family history of seizures or progressive neurological disease
• •Family history of congenital or hereditary immunodeficiency
• •Women of pregnancy, lactation or about to be pregnant in 60 days
• •Autoimmune disease or immunodeficiency
• •Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
• •Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 7days
• •Any active infections and received any antibiotic or anti-virus treatments in the last 7 days
• •Had a fever in the last 3 days, with temperature ≥37.1°C
• •Participate in another clinical trials
• •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
• •Revaccination period: The nonresponders to receive second or/and third 60mcg recombinant hepatitis B vaccines:
• •Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
• •Serious adverse reactions to vaccines
• •Active infections
• •Subjects who want to quit the study
• •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives