Antigen-specific Immune Response to Hepatitis B Virus in Utero

Hepatitis B Clinical Trial

Official title:

Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00845403
• Other study ID #: DSRB D/08/376
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2009
• Last updated: January 10, 2014
• Start date: September 2008
• Est. completion date: December 2016

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women with HBsAg+

Exclusion Criteria:

• Pregnant women without HBsAg+

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers	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.	At birth (baseline)	No
Secondary	Expression of immune genes from immune cells	Expression of immune gene cells was measured using Nanostring technology and epigenetic analysis.	At birth (baseline)	No