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

This is an interventional prevention trial for Hepatitis b focused on measuring immunogenicity, safety, recombinant hepatitis B vaccine, nonresponders Read More

Inclusion Criteria :

Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:

• Healthy subjects aged 16 and older as established by medical history and clinical examination
• The subjects or their guardians are able to understand and sign the informed consent
• Had never received the hepatitis B vaccines
• Subjects who can and will comply with the requirements of the protocol

Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:

• Healthy subjects aged 16 and older as established by medical history and clinical examination
• The subjects or their guardians are able to understand and sign the informed consent
• After the routine administration of 10mcg hepatitis B vaccines, the peak period levels of anti-HBs is lower than 10mIU/ml
• Subjects with temperature <37.1°C on axillary setting
• Subjects who can and will comply with the requirements of the protocol

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