Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers

Govind Ballabh Pant Hospital

Status

Completed

Conditions

Chronic Hepatitis B

Treatments

Drug: Vaccine+HBIG

Drug: Vaccine+Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01412567

LHMC-1

Details and patient eligibility

About

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.

Enrollment

259 patients

Sex

All

Ages

Under 1 day old

Volunteers

Accepts Healthy Volunteers

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.