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

This study has been completed.
Sponsor:
Collaborators:
Indian Council of Medical Research
Lady Hardinge Medical College
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01412567
First received: August 8, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

August 8, 2011
August 8, 2011
October 2005
June 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Chronic Hepatitis B
  • 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
  • Active Comparator: Vaccine+HBIG
    Intervention: Drug: Vaccine+HBIG
  • Placebo Comparator: Vaccine+Placebo
    Intervention: Drug: Vaccine+Placebo
Pande C, Sarin SK, Patra S, Kumar A, Mishra S, Srivastava S, Bhutia K, Gupta E, Mukhopadhyay CK, Dutta AK, Trivedi SS. Hepatitis B vaccination with or without hepatitis B immunoglobulin at birth to babies born of HBsAg-positive mothers prevents overt HBV transmission but may not prevent occult HBV infection in babies: a randomized controlled trial. J Viral Hepat. 2013 Nov;20(11):801-10. doi: 10.1111/jvh.12102. Epub 2013 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
259
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
up to 1 Day
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01412567
LHMC-1
No
Prof Shiv Kumar Sarin, G B Pant Hospital
Govind Ballabh Pant Hospital
  • Indian Council of Medical Research
  • Lady Hardinge Medical College
Not Provided
Govind Ballabh Pant Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP