Status:
COMPLETED
Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Hepatitis B
Eligibility:
All Genders
Up to 49 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of the recombinant hepatitis B vaccine (Hansenula polymorpha, 10μg), with an open-labelled design in adults and randomized, doubl...
Detailed Description
This is a phase Ⅰ clinical trial of recombinant hepatitis B vaccine (Hansenula polymorpha,10μg) with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2021
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04075201
Start Date
July 7 2019
End Date
July 25 2021
Last Update
July 29 2021
Active Locations (1)
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1
Biyang County Center for Disease Control and Prevention
Zhumadian, Henan, China, 463700