NCT01412567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

Enrollment Period

4.7 years

First QC Date

August 8, 2011

Last Update Submit

August 8, 2011

Conditions

Chronic Hepatitis B

Keywords

Hepatitis BHBsAgAntenatalPregnancyVertical transmissionPlacentaHBV DNA

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Vaccine+HBIG

ACTIVE COMPARATOR
Drug: Vaccine+HBIG

Vaccine+Placebo

PLACEBO COMPARATOR
Drug: Vaccine+Placebo

Interventions

Vaccine+HBIGDRUG

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

Vaccine+HBIG
Vaccine+PlaceboDRUG

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

Vaccine+Placebo

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Newborn babies of mothers who were found to be HBsAg positive

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

Location

Related Publications (1)

  • 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.

    PMID: 24168259DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 9, 2011

Study Start

October 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations

IN(1)