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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00845403

Enrollment

Registered

2009-02-18

Start date

2008-09-30

Completion date

2016-12-31

Last updated

2014-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B carrier

Brief summary

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.

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Pregnant women with HBsAg+

Exclusion criteria

* Pregnant women without HBsAg+

Design outcomes

Primary

Measure	Time frame	Description
Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers	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

Measure	Time frame	Description
Expression of immune genes from immune cells	At birth (baseline)	Expression of immune gene cells was measured using Nanostring technology and epigenetic analysis.

Countries

Singapore

Outcome results