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

Sponsor

Govind Ballabh Pant Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01412567

Collaborator

Indian Council of Medical Research (Other), Lady Hardinge Medical College (Other)

259

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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	Phase
Chronic Hepatitis B	Drug: Vaccine+HBIG Drug: Vaccine+Placebo	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2005

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

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

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Day

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.