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Hepatitis C Virus and the Humoral Immune System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00219999
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 9, 2013
National Institute of Allergy and Infectious Diseases (NIAID)
New York Presbyterian Hospital
Information provided by (Responsible Party):
Rockefeller University

Brief Summary:
The purpose of this study is to measure specific chemokines, antibodies, and antibody-producing B cells in the blood of patients with hepatitis C virus (HCV) infection. Our hypothesis is that changes in chemokine levels affect the development of an effective immune response against HCV.

Condition or disease
Hepatitis C Virus

Detailed Description:

The long-term goal of our research is to understand why immune complexes (ICs) are produced in patients infected with HCV, and whether these complexes affect virus interaction with target cells. We have found that many patients infected with HCV have an increased frequency of circulating B cells, but no evidence that the increased B cells are activated of proliferating. One possible mechanism for such an increase would be a change in levels of chemokines that influence B cell localization and trafficking. Our studies are aimed at testing the following hypotheses:

  1. One hypothesis is that HCV infection results in increased levels of specific cytokines and chemokines that may affect the motility and localization of immature and mature B cells. An alternative model is that HCV infection leads to chronic antigenic stimulation of B lymphocytes, and that the abnormalities of B cell function associated with HCV infection reflect this chronic antigenic stimulation.
  2. A second hypothesis is that autoantibodies and immune complexes present in HCV patient serum contribute to the persistence and spread of viral infection.

To test these hypotheses, we are measuring levels of chemokines, the frequency of circulating B cells (mature resting B cells, mature activated B cells, memory B cells, and immature B cells), and the levels and components of ICs in the blood of HCV-infected patients. Controls include healthy volunteers and patients with chronic liver disease unrelated to HCV infection. No interventions in patient care are planned. When patients elect to undergo standard antiviral therapies under the supervision of their hepatologists, we will study the outcomes of therapy (no virologic response, partial or transient virologic response, sustained virologic response) to determine whether any of the observed alterations in chemokine levels, B cell frequency or activation, or immune complex levels correlate with the patient's response to antiviral therapy.

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Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hepatitis C Virus and the Humoral Immune System
Study Start Date : September 2001
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

HCV infection
current HCV infection, including intravenous drug users
cryoglobulinemia and without HCV infection
chronic liver disease
chronic liver disease not due to hepatitis C virus infection
Sustained Virologic responders
successfully treated for HCV infection
normal, healthy volunteers

Primary Outcome Measures :
  1. Define the relationships between HCV infection, B cell phenotype, and B cell function [ Time Frame: 5 years ]
    Define the relationships between HCV infection, B cell phenotype, and B cell function

Biospecimen Retention:   Samples With DNA
whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinics of doctors at NYPH and the NYC metropolitan area

Inclusion Criteria:

  • Healthy volunteers, no liver disease
  • Chronic infection with hepatitis C virus
  • Other chronic liver disease unrelated to hepatitis C virus
  • Subjects in all groups must have sufficiently healthy veins to allow blood collection.

Exclusion Criteria:

  • Any medical condition that, in the opinion of the investigators, precludes the patient's participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00219999

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United States, New York
Rockefeller University Hosital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
National Institute of Allergy and Infectious Diseases (NIAID)
New York Presbyterian Hospital
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Principal Investigator: Lynn B Dustin, PHD Rockefeller University
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rockefeller University Identifier: NCT00219999    
Other Study ID Numbers: LDU-0437
R01AI060561 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013
Keywords provided by Rockefeller University:
B Lymphocytes
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections