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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
259
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
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
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, India
remaining free of any HBV infection (either overt or occult) plus development of adequate immune response to vaccine at 18 weeks of age
Time frame: 18 weeks
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