Antigen-specific Immune Response to Hepatitis B Virus in Utero

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National University Hospital, Singapore
Sponsor:
Information provided by (Responsible Party):
Obstetrics & Gynaecology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00845403
First received: February 16, 2009
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition
Hepatitis B

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers [ Time Frame: At birth (baseline) ] [ Designated as safety issue: No ]
    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:
  • Expression of immune genes from immune cells [ Time Frame: At birth (baseline) ] [ Designated as safety issue: No ]
    Expression of immune gene cells was measured using Nanostring technology and epigenetic analysis.


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.


Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Pregnant women with HBsAg+

Exclusion Criteria:

  • Pregnant women without HBsAg+
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845403

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Yap Seng Chong, MBBS    67724286    obgcys@nus.edu.sg   
Principal Investigator: Yap Seng Chong, MBBS         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Yap Seng Chong, MBBS National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Obstetrics & Gynaecology, Associate Professor Chong Yap Seng, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00845403     History of Changes
Other Study ID Numbers: DSRB D/08/376
Study First Received: February 16, 2009
Last Updated: January 10, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Hepatitis B carrier

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
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 September 18, 2014