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

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ClinicalTrials.gov Identifier: NCT01412567
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : August 9, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Chronic Hepatitis B Drug: Vaccine+HBIG Drug: Vaccine+Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : October 2005
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Vaccine+HBIG 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
Placebo Comparator: Vaccine+Placebo 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

Outcome Measures

Primary Outcome Measures :
  1. remaining free of any HBV infection (either overt or occult) plus development of adequate immune response to vaccine at 18 weeks of age [ Time Frame: 18 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412567

Lady Hardinge Medical College
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Indian Council of Medical Research
Lady Hardinge Medical College
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Shiv Kumar Sarin, G B Pant Hospital
ClinicalTrials.gov Identifier: NCT01412567     History of Changes
Other Study ID Numbers: LHMC-1
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Govind Ballabh Pant Hospital:
Hepatitis B
Vertical transmission

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs