Antigen-specific Immune Response to Hepatitis B Virus 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero|
- 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.
- 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.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845403
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Yap Seng Chong, MBBS 67724286 firstname.lastname@example.org|
|Principal Investigator: Yap Seng Chong, MBBS|
|Principal Investigator:||Yap Seng Chong, MBBS||National University Hospital, Singapore|