- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01412567
Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers
August 8, 2011 updated by: Govind Ballabh Pant Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
259
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110001
- Lady Hardinge Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 day (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 18 weeks
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
August 8, 2011
First Submitted That Met QC Criteria
August 8, 2011
First Posted (Estimate)
August 9, 2011
Study Record Updates
Last Update Posted (Estimate)
August 9, 2011
Last Update Submitted That Met QC Criteria
August 8, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- LHMC-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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