Effect and long-term protection of 10ug Ha Hepatitis B Vaccine combined different doses of HBIG on preventing mother to child transmission of HBV

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-PRC-12002790

Enrollment

Unknown

Registered

2012-11-23

Start date

2012-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B virus

Interventions

1:10ug Recombinant Hepatitis B Vaccine Expressed in Hansenula Yeast combined with 100IU HBIG

2:10ug Recombinant Hepatitis B Vaccine Expressed in Hansenula Yeast combined with 200IU HBIG

Eligibility

Sex/Gender

All

Age

No minimum to 4 Years

Inclusion criteria

Inclusion criteria: Pregnant womenHBsAg positive; ALT less than 2 times the upper limit of normal, normal total bilirubin; no serious obstetric complications. InfantsBorn to HBsAg-positive mothers; full-term newborns (37-42 weeks' gestational age); Apgar score at birth of not less than 7 point; normal body temperature at birth (axillary temperature =2500 g; jaundice index of neonatal in the normal range (allowing physiological jaundice); Informed consent were signed by the parents or guardians; individuals could comply with the requirements of the clinical trials according to the judgment of investigators.

Exclusion criteria

Exclusion criteria: Pregnant women:Existence of pathological states in obstetrics, such as pre-eclampsia, placenta previa, placental abruption and amniotic fluid embolism; undergoing antiviral therapy, or treated with Hormones or immunosuppressive agents; existence of autoimmune liver disease, severe hepatitis and cirrhosis, or co-infection with other viruses (such as HCV and HIV). Infants:Acute infection (judged by the clinician, such as respiratory infections, etc.); exiting the clinical trials automatically; having a family history of convulsions, epilepsy and encephalopathy; whose mother were immunocompromised or having a history of organ transplant or blood dialysis; whose parents have HepB yeast allergy; having a history of thrombocytopenia or coagulopathy, and not suitable for intramuscular; deficiency on immune functions; may affect test assessment according to the judgment of the investigators.

Design outcomes

Primary

Measure	Time frame
HBsAg;anti-HBs;HBeAg;anti-HBe;anti-HBc;HBV DNA;	—

Secondary

Measure	Time frame
Genotype of HBV;	—

Countries

China

Contacts

Public ContactJie Li

jielipku@gmail.com+86 13501285783

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026