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

Not Applicable

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Vaccine+HBIG; Drug: Vaccine+Placebo

• Registration Number: NCT01412567
• Lead Sponsor: Govind Ballabh Pant Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-08
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-08
• Last Update Submitted: 2011-08-08
• Study First Posted: 2011-08-09
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine+HBIG	Vaccine+HBIG	-
Vaccine+Placebo	Vaccine+Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lady Hardinge Medical College; 🇮🇳 New Delhi, Delhi, India