Antigen-specific Immune Response to Hepatitis B Virus in... | NCT00845403

Studies
Antigen-specific Immune Response to Hepatitis B Virus in Utero

NCT00845403

Sponsor

National University Hospital, Singapore

Status

Unknown status

Last Update Posted

Jan 13, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Hepatitis B

Interventions

Not provided

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 16, 2009

First Submission Date that Met QC Criteria

Feb 16, 2009

First Posted Date

Feb 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2014

Last Update Posted Date

Jan 13, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Obstetrics & Gynaecology, Associate Professor Chong Yap Seng, National University Hospital, SingaporePrincipal Investigator

Lead Sponsor

National University Hospital, SingaporeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women with HBsAg+

Exclusion Criteria:

Pregnant women without HBsAg+

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yap Seng Chong, MBBS	National University Hospital, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital	Recruiting	Singapore		119074	Singapore

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

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.