Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers
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Purpose
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 | Intervention |
|---|---|
|
Chronic Hepatitis B |
Drug: Vaccine+HBIG Drug: Vaccine+Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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 |
- 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 ]
| Enrollment: | 259 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | up to 1 Day |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Prof Shiv Kumar Sarin, G B Pant Hospital |
| ClinicalTrials.gov Identifier: | NCT01412567 History of Changes |
| Other Study ID Numbers: | LHMC-1 |
| Study First Received: | August 8, 2011 |
| Last Updated: | August 8, 2011 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Govind Ballabh Pant Hospital:
|
Hepatitis B HBsAg Antenatal Pregnancy |
Vertical transmission Placenta HBV DNA |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on June 18, 2013