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

February 25, 2015 updated by: Vaccine and Gene Therapy Institute, Florida
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University Health System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic HBV
chronic HBV strata: HBV tolerant, Chronic active HBe+ or HBe-, suppressed with antiviral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaccine and Gene Therapy Institute, Florida

Investigators

  • Principal Investigator: Richard Sterling, MD, Virginia Commonwealth University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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