Chronic Hepatitis B
Conditions
Keywords
Hepatitis B, HBsAg, Antenatal, Pregnancy, Vertical transmission, Placenta, HBV DNA
Brief summary
Prevention of perinatal transmission is essential to decrease the global burden of chronic HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to the newborns of HBsAg positive mothers is the standard of care for prevention of HBV in babies. Some studies have however, shown that vaccine alone may be equally effective. Hence, immunoprophylaxis with hepatitis B vaccine with or without HBIG is effective in prevention of transmission of overt HBV infection to the babies. The primary outcome measure of most of the trials on immunoprophylaxis was the occurrence of hepatitis B, defined as a blood specimen positive for hepatitis B surface antigen (HBsAg). However, whether this immunoprophylaxis also prevents HBsAg negative HBV infection (occult HBV infection) in babies is not known. In the present study the investigators evaluated the efficacy of the two regimens; vaccination alone and compared it with vaccination plus HBIG administration at birth in preventing transmission of both overt and occult HBV infection to the newborn babies.
Interventions
DRUGVaccine+HBIG
Recombinant hepatitis B vaccine at birth, 6 weeks, 10 weeks, and 14 weeks in the dose of 10 mcg (0.5 mL), by intramuscular injection in the anterolateral thigh; PLUS HBIG in the dose of 0.5 mL intramuscularly immediately after birth
DRUGVaccine+Placebo
Recombinant hepatitis B vaccine at birth, 6 weeks, 10 weeks, and 14 weeks in the dose of 10 mcg (0.5 mL), by intramuscular injection in the anterolateral thigh; PLUS placebo intramuscularly immediately after birth
Sponsors
Indian Council of Medical Research
Lady Hardinge Medical College
Govind Ballabh Pant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
Yes
Inclusion criteria
* Newborn babies of mothers who were found to be HBsAg positive
Exclusion criteria
* Babies of mothers who had any symptoms of liver disease during the pregnancy such as jaundice, pruritus, ascites, or gastrointestinal bleed; * Babies of mothers taking anti-viral treatment during pregnancy; * Babies of mother with pregnancy related complications; and * Babies of mothers who refused to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remaining free of any HBV infection (either overt or occult) plus development of adequate immune response to vaccine at 18 weeks of age | 18 weeks |
Countries
India
Outcome results
None listed