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

• Conditions: Chronic Hepatitis B

• Registration Number: NCT02017587
• Lead Sponsor: Vaccine and Gene Therapy Institute, Florida

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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-25
• Last Update Posted: 2015-02-26
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T lymphocyte phenotype and functional response in chronic HBV infection	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

Trial Locations

Locations (1)

Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States