Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis B
- Sponsor
- Vaccine and Gene Therapy Institute, Florida
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- T lymphocyte phenotype and functional response in chronic HBV infection
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
T lymphocyte phenotype and functional response in chronic HBV infection
Time Frame: Baseline
Phenotype CD4+ and CD8+ subsets - activation markers and negative regulators - CD4+ functional response. Expression of programmed death 1 (PD-1) and its ligand (PD-L1/B7-H1) on viral antigen-specific T-cells