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

February 16, 2009
January 10, 2014
September 2008
December 2016   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00845403 on ClinicalTrials.gov Archive Site
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.
Not Provided
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Antigen-specific Immune Response to Hepatitis B Virus in Utero
Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Probability Sample

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.

Hepatitis B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women with HBsAg+

Exclusion Criteria:

  • Pregnant women without HBsAg+
Female
21 Years to 45 Years
Yes
Singapore
 
NCT00845403
DSRB D/08/376
Yes
Obstetrics & Gynaecology, National University Hospital, Singapore
National University Hospital, Singapore
Not Provided
Principal Investigator: Yap Seng Chong, MBBS National University Hospital, Singapore
National University Hospital, Singapore
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP