Identification of Hepatitis C Virus (HCV) Specific T Cells (TETRA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01534728
First received: February 14, 2012
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of the global population. Contrary to other chronic infections such as HIV, clearance of HCV is possible. While much is now known about the response to treatment in chronic HCV patients, the fact that acute HCV infection is typically asymptomatic (~80% of patients show no clinical signs) has made it challenging to define the mechanisms involved in spontaneous clearance.

Immune protection against HCV is thought to be largely dependent upon the CD8 T cell response. Therefore using the latest T cell detection technology the investigators will develop a panel of tetramers specific for all potential HCV epitopes. To produce the tetramers the investigators will utilize HLA ligand exchange technology which allows the production of very large collections of peptide-HLA multimers for T cell staining. The investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T cell epitopes using published viral sequences and algorithm prediction databases. Using this information the investigators are currently in the process of developing collections of peptide-HLA multimers for T cell staining. Therefore the investigators require large lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each tetramer on the CD3+CD8+ T cells.

The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be able to test and compare the frequency of possible conserved epitopes present in both HCVg1 and HCVg4 infections. Once developed this technique will allow us to examine all virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller quantities of blood. The development of these technologies will also allow us to tailor such future diagnostic tests to local populations where a viral subspecies is prevalent; for example using North-African HLA alleles for HCVg4 epitopes.

The work carried out using such assays will provide important immunological correlates of viral clearance that will impact vaccine design for HCV infections. Finally, the identification of protective CD8 T cells specific for HCV may allow new diagnostic tools with predictive powers of disease progression that can be used on any flow cytometer machine.


Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of HCV Specific T Cells Using Tetramer Technology - TETRA Study

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Biospecimen Retention:   Samples Without DNA

PBMCs


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic HCV Patients

Criteria

Inclusion Criteria:

  • Male or female subjects
  • Age between 18 and 60 years
  • Signed Consent Form
  • Patient affiliated to social security
  • Infection with HCV genotype 1 or 4 : infection defined by the presence of HCV antibodies and HCV RNA in plasma allowing a measure of the circulating viral load, or resolved infection as defined by the presence of antibodies HCV, normal transaminases and negative HCV RNA measured by PCR (two consecutive tests)
  • Normal ECG in the judgment of the investigator
  • Venous access allowing a leukapheresis
  • Review hematologic allowing the realization of a leukapheresis to investigator assessment.

Exclusion Criteria:

  • Patients being treated for HCV
  • HBV infection defined by the presence of HBsAg (serology already known, test not done specifically for research)
  • HIV infection defined by the detection of HIV antibodies (serology already known, test not done specifically for research)
  • Patients with cirrhosis
  • Patients addicted to narcotics use
  • Patients with excessive alcohol consumption (more than 3 units per day)
  • Pregnancy
  • Contraindications to leukapheresis
  • History of vasculitis related or unrelated to HCV
  • A person deprived of liberty by judicial or administrative decision.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534728

Contacts
Contact: Stanislas POL, MD, PhD +33(0)1 58 41 30 01 stanislas.pol@cch.aphp.fr
Contact: Vincent MALLET, MD, PhD +33(0)1 58 41 30 01 vincent.mallet@cch.aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75014
Principal Investigator: Stanislas POL, MD, PhD         
Sub-Investigator: Vincent MALLET, MD, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Matthew L. ALBERT, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01534728     History of Changes
Other Study ID Numbers: C11-33, 2011-A01226-35
Study First Received: February 14, 2012
Last Updated: February 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Hepatitis C
CD8 epitopes

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014