Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)

This is an interventional prevention trial for Hepatitis B Read More

Inclusion Criteria:

• Adults aged 18~49 years, or children aged 1~15 years, or neonates within 24 hours of birth;
• Proven legal identity;
• Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment ;

Exclusion Criteria (For Adults):

• Breast feeding, pregnant, or expected to conceive in the next 60 days;
• History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
• Congenital malformation, developmental disorders, genetic defects;
• Autoimmune disease or immunodeficiency/immunosuppressive;
• Severe chronic diseases, severe cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver Kidney disease, malignant tumor;
• Severe nervous system disease or mental illness;
• Asplenia or functional asplenia;
• Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
• Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
• Long term history of alcoholism or drug abuse;
• Administration of blood product within 3 months prior to the entry;
• Administration of any other investigational drugs within 30 days prior to the entry;
• Receipt of any attenuated live vaccine within 14 days prior to study entry;
• Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
• Any acute disease within 7 days prior to the study entry;
• Axillaty temperature > 37.0 °C;
• Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Exclusion Criteria (For Children):

• History of extra vaccination of Hepatitis B vaccine or vaccine containing hepatitis B except for the primary vaccination in the immunization planning program;
• History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
• Congenital malformation, developmental disorders, genetic defects;
• Autoimmune disease or immunodeficiency/immunosuppressive;
• Severe chronic diseases, severe cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver Kidney disease, malignant tumor;
• Severe nervous system disease or mental illness;
• Asplenia or functional asplenia;
• Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
• Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry; Long term history of alcoholism or drug abuse;
• Administration of blood product within 3 months prior to the entry;
• Administration of any other investigational drugs within 30 days prior to the entry;
• Receipt of any attenuated live vaccine within 14 days prior to study entry;
• Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
• Any acute disease within 7 days prior to the study entry;
• Axillaty temperature > 37.0 °C;
• Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Exclusion Criteria (For Neonates):

• Neonates gestational age <37 weeks or >42 weeks;
• Birth weight <2500g for boy, <2300g for girl;
• Apgar score at birth <8;
• Positive for any of the mother's HBsAg, HBeAg, HBeAb, and HBcAb (check the laboratory report of the birth hospital);
• Parents have family history of convulsions, epilepsy, encephalopathy, etc.;
• Mother's immune function is low or history of organ transplantation or hemodialysis;
• Mother has history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
• Family history of coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
• Immune system function damage, or parents have autoimmune diseases or immunodeficiency/immunosuppression;
• Congenital malformation, developmental disorders, genetic defects;
• Diognosed or suspected of active infection, cardiovascular disease, etc.;
• Axillaty temperature > 37.0 °C;
• Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.