Antigen-specific Immune Response to Hepatitis B Virus in Utero
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Hepatitis B |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Antigen-specific Immune Response to Hepatitis B Virus in Utero |
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.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | August 2010 (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.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
Inclusion Criteria:
- Pregnant women with HBsAg+
Exclusion Criteria:
- Pregnant women without HBsAg+
Contacts and Locations| Singapore | |
| National University Hospital | Recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Yap Seng Chong, MBBS 67724286 obgcys@nus.edu.sg | |
| Principal Investigator: Yap Seng Chong, MBBS | |
| Principal Investigator: | Yap Seng Chong, MBBS | National University Hospital, Singapore |
More Information
No publications provided
| Responsible Party: | Chong Yap Seng, Associate Professor, National University Hos[ota; |
| ClinicalTrials.gov Identifier: | NCT00845403 History of Changes |
| Other Study ID Numbers: | DSRB D/08/376 |
| Study First Received: | February 16, 2009 |
| Last Updated: | September 18, 2009 |
| Health Authority: | Singapore: Health Sciences Authority |
Keywords provided by National University Hospital, Singapore:
|
Hepatitis B carrier |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Viral, Human Liver Diseases Digestive System Diseases |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 16, 2013