Antigen-specific Immune Response to Hepatitis B Virus in Utero

NCT00845403 | Unknown DMC

• 1 other identifier: DSRB D/08/376
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Keywords

Hepatitis B carrier

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Expression of immune genes from immune cells

  At birth (baseline)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

HBsAg+ mothers are the source of possible in utero infection.Thus, the cord blood collected from these mothers after delivery would provide information about the cause of HBV chronicity in Asian patients and about the management of baby born from HBsAg+ mothers.

You may qualify if:

• Pregnant women with HBsAg+

You may not qualify if:

• Pregnant women without HBsAg+

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord Blood of HBsAg+ mothers will be collected at delivery after seeking informed consent. Mononuclear cells (T cells and monocytes) will be isolated.Purified populations of T cells will be stimulated with different mixtures of HBV peptides covering HBV proteins and experiments of ELISPOT or intracellular cytokine staining will be carried out to detect the specificty of the responsive T cell population. In addition, T cells willbe stained with HLA-tetramers specific for different HBV epitopes to directly analyze the frequency and phenotype of HBV-specific CD8+Tcells present in cord blood.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Yap Seng Chong, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Chong Yap Seng

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: September 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

SG (1)