This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained
from the phase 1 clinical trial. The purpose of this study is to further evaluate the
immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16
and older who failed to respond to routine administration of 10mcg recombinant hepatitis B
vaccines and to explore the optimizing immunizing dose and immune procedure.
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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