Antigen-specific Immune Response to Hepatitis B Virus in Utero

• Conditions: Hepatitis B

• Registration Number: NCT00845403
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers.

Detailed Description

Despite the development of an effective preventive HBV vaccine, the spread of HBV virus continue, particularly in Asia, where the majority of HBV infection is acquired at birth by vertical transmission from mother to baby. HBV vertical transmission has been hypothesized to cause immune tolerance to HBV and thus promoting the subsequent HBV chronicity. Such hypothesis has never been tested and nothing is known about HBV-specific adaptive immune response occurring before birth in baby born form HBV chronically infected mothers. This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers. The characterization of the HBV immune response in utero will provide informations about the cause of HBV chronicity in Asian patients in the management of baby born from HBsAg+ mothers.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-02-16
• Study First Submitted QC: 2009-02-16
• Study First Posted: 2009-02-18
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-13
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Pregnant women with HBsAg+

Exclusion Criteria

• Pregnant women without HBsAg+

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers	At birth (baseline)	Immune response was defined as activation of innate immune effectors (NK cells, monocytes) and production of TH1 cytokines IL - 2, TNF - a and IFN - g from T cells.

Secondary Outcome Measures

Name	Time	Method
Expression of immune genes from immune cells	At birth (baseline)	Expression of immune gene cells was measured using Nanostring technology and epigenetic analysis.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore