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Antigen-specific Immune Response to Hepatitis B Virus in Utero

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Obstetrics & Gynaecology, National University Hospital, Singapore.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845403
First Posted: February 18, 2009
Last Update Posted: January 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Obstetrics & Gynaecology, National University Hospital, Singapore
  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 Obstetrics & Gynaecology, 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) ]
    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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 16, 2009
First Posted: February 18, 2009
Last Update Posted: January 13, 2014
Last Verified: January 2014

Keywords provided by Obstetrics & Gynaecology, 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


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