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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02017587
• Other study ID #: HBV-001
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2013
• Last updated: February 25, 2015
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Vaccine and Gene Therapy Institute, Florida
• Contact: Patrick D Yeramian, MD
• Phone: 772 345 5669
• Email: pyeramian[@]vgtifl.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Health System	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Vaccine and Gene Therapy Institute, Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T lymphocyte phenotype and functional response in chronic HBV infection	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	Baseline	No