The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines
Hepatitis b
About this trial
This is an interventional prevention trial for Hepatitis b focused on measuring immunogenicity, safety, recombinant hepatitis B vaccine, nonresponders
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
60mcg/1.0ml recombinant hepatitis B vaccine
30mcg/1.0ml recombinant hepatitis B vaccine
10mcg/1.0ml recombinant hepatitis B vaccine
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.