Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2013 |
| End Date: | December 2015 |
| Contact: | Patrick D Yeramian, MD |
| Email: | pyeramian@vgtifl.org |
| Phone: | 772 345 5669 |
The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from
approximately 40 chronic HBV for biomedical research program led by VGTI Florida.
approximately 40 chronic HBV for biomedical research program led by VGTI Florida.
During chronic HBV infection, a dynamic balance between viral replication and the host
immune response is pivotal to the pathogenesis of liver disease. HBV specific T-cell
function is impaired in patients with chronic HBV infection characterized by low levels of
antiviral cytokines, impaired cytotoxic T lymphocyte activity, and persistent viremia.
However, the mechanism underlying this T-cell malfunction in chronic HBV infection has not
been completely understood.
The biomedical research on the samples obtained during this study will include, among other
studies, advanced flow cytometry to study the Treg and activation markers, negative
regulatory molecules and phenotype of CD4 and CD8 subsets using the extended panel markers
developed at VGTI Florida. Additional antibody panels for measuring functional CD4 responses
by ICS, DC subsets, activation, and signaling pathways by phos
immune response is pivotal to the pathogenesis of liver disease. HBV specific T-cell
function is impaired in patients with chronic HBV infection characterized by low levels of
antiviral cytokines, impaired cytotoxic T lymphocyte activity, and persistent viremia.
However, the mechanism underlying this T-cell malfunction in chronic HBV infection has not
been completely understood.
The biomedical research on the samples obtained during this study will include, among other
studies, advanced flow cytometry to study the Treg and activation markers, negative
regulatory molecules and phenotype of CD4 and CD8 subsets using the extended panel markers
developed at VGTI Florida. Additional antibody panels for measuring functional CD4 responses
by ICS, DC subsets, activation, and signaling pathways by phos
Inclusion Criteria:
- Patient with chronic HBV infection documented by presence of HBsAg for at least 12
months currently untreated for HBV infection or under stable antiviral therapy
Exclusion Criteria:
- Prior use of HBV therapeutic vaccine
- Currently treated with interferon alpha or other immune modulator(s)
- Acute HBV infection
- Chronic inactive HBV carrier
- under an acute flare/reactivation of HBV infection defined as symptoms of acute
hepatitis and recent elevation of aminotransferase (over 10 x ULN) or bilirubin
levels
- Known co-infection with HCV, HDV, and/or HIV
- Under renal dialysis
- For female patients, pregnant or breastfeeding
- Cirrhosis, hepatocellular carcinoma or liver transplantation
- active autoimmune disease including autoimmune hepatitis
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