NCT00845403|UnknownDMC
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Sponsor study identifier
observational
60
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 16, 2009
Actual (reported)February 18, 2009
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Expression of immune genes from immune cells
At birth (baseline)
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.
National University Hospital
Singapore, 119074, Singapore
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.
Yap Seng Chong, MBBS
National University Hospital, Singapore
First Submitted
February 16, 2009
First Posted
February 18, 2009
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 13, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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