Clinical trial NCT01412567: Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B
HBsAg
Antenatal
Pregnancy
Vertical transmission
Placenta
HBV DNA
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Indian Council of Medical Research
name: Lady Hardinge Medical College
First posted: 2011-08-09
Enrollment: 259
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: remaining free of any HBV infection (either overt or occult) plus development of adequate immune response to vaccine at 18 weeks of age
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical College
state: Delhi
Study officials:
References:
citation: 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.