Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Govind Ballabh Pant Hospital
Collaborators:
Indian Council of Medical Research Lady Hardinge Medical College