NCT01412567

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

Comparison of Recombinant Hepatitis B Vaccine Plus Hepatitis B Immune Globulin (HBIG) Versus Vaccine Plus Placebo for Prophylaxis of Hepatitis B Infection in Newborns of Hepatitis B Surface Antigen (HBsAg) Positive Mothers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Govind Ballabh Pant Hospital · Other Government
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Vaccine+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
DRUG	Vaccine+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

Timeline

• Start date: 2005-10-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2011-08-09
• Last updated: 2011-08-09

Locations

1 site across 1 country: India