At high risk of infection with hepatitis B virus
Conditions
Interventions
Group A:20µg of Hepatits B vaccine at 0,1 and 6 months of age, with 200 IU hepatitis B immunoglobulin (HBIG) at birth and a 2nd dose at the 1st month.
Group B:10ug of Hepatits B vaccine at 0,1 and 6 months of age, with 200 IUHBIG at birth and a 2nd dose at the 1st month
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 24 Years
Inclusion criteria
Inclusion criteria: 1. Newborn Gestational age>=37weeks; 2. Born to mothers with HBsAg positive more than 6 months; 3. Born to mothers aged 18 to 45 years old; 4. Born to mothers with documented tests for HBV-serology and HBV DNA within 1 months prior to delivery; 5. Signed informed consent obtained from the newborn's parents or legal guardians.
Exclusion criteria
Exclusion criteria: 1. Newborn Birth weight ==37.5 degree C; 4. Family history of immunodeficiency; 5. Mother has coinfection with hepatitis C, hepatitis E, HIV, Cytomegalovirus, EBV, herpes virus, Rubella virus, pallidin or Toxoplasma gondii; 6. Mother has ALT levels >=2 times the upper limit of normal (ULN); 7. Mother has total serum bilirubin levels >=2 ULN; 8. Mother has Albumin levels=<25g/L; 9. Mother has liver cirrhosis, thyroid disease, diabetes, severe retinal disease or astable or conspicuous angiocardiopathy such as angina cordis, heart failure; 10. Mother has any immunologically compromised conditions (including malignant tumor); 11. Mother had treatment withf interferon, immunomodulator, or any nucleoside analog that is active against hepatitis virus within 6 months before pregnancy; 12. Mother had long term use (defined as more than 28 days) of parenteral steroids or other immune-modifying drugs within six months prior to pregnancy; 13. Mother had treatment with anti- hepatitis virus B drugs during pregnancy; 14. Mother treated with immunosuppressive(including steroids) or immunostimulant therapy(including HBIG) during pregnancy; 15. Mother is currrently or will participate any other clinical trial during pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hepatitis B surface antigen(HBsAg);Anti- HBs antibody concentrations;Anti-hepatitis B surface antigen(anti-HBs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum HBV DNA;hepatitis e antigen (HBeAg), anti-hepatitis e antigen (anti-HBe) and anti-hepatitis core antigen (anti-HBc); | — |
Countries
China
Contacts
Public ContactZhongping Duan
Outcome results
None listed