Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection
Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection
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.
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
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