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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Vaccine+HBIG
* Drug: Vaccine+Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaccine+HBIG<br> | Drug: Vaccine+HBIG<br>* 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<br>|
| Placebo Comparator: Vaccine+Placebo<br> | Drug: Vaccine+Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, HBsAg, Antenatal, Pregnancy, Vertical transmission, Placenta, HBV DNA