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

Information source: Govind Ballabh Pant Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: Vaccine+HBIG (Drug); Vaccine+Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Govind Ballabh Pant Hospital

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: remaining free of any HBV infection (either overt or occult) plus development of adequate immune response to vaccine at 18 weeks of age

Eligibility

Minimum age: N/A. Maximum age: 1 Day. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Lady Hardinge Medical College, New Delhi, Delhi 110001, India
Additional Information

Starting date: October 2005
Last updated: August 8, 2011

Page last updated: August 20, 2015

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