Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured

December 28, 2016 updated by: Hospices Civils de Lyon

Performance of the Hepatitis B Virus (HBV) ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured

Activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases.

Transgene is developing a therapeutic vaccine "TG1050" for the treatment of patients with chronic and treated Hepatitis B. This biotherapy compound is for the development of T cellular immune response in these patients in order to achieve the total elimination of infected cells.

Therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

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

  • France
      • Lyon, France, 69004
        • Hôpital de La Croix Rousse

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

Hepatitis B infected patients or cured

Description

Inclusion Criteria:

Man or woman aged ≥18 years old.

Patients with chronic hepatitis B regardless of the genotype.

  • treated with nucleotide analogs approved for the treatment of hepatitis B.
  • or untreated.
  • with a positive or negative antigen HBe
  • regardless of the level of transaminases.

Patients with a history of HBV infection (recovered) with seroconversion of antigen HBs spontaneously or under treatment.

Patient with a general state ranging 0 or 1 on the ECOG scale (Eastern Cooperative Oncology Group)

Patient who signed the informed consent

Patient with a social security affiliation

Exclusion Criteria:

patients co-infected with human immunodeficiency virus (HIV) or Hepatitis C virus (HCV).

Patients treated with interferon, immunosuppressive, or experimental treatment consisting of an unapproved molecule for the treatment of hepatitis B.

Patient unable to meet the constraints of the study

Patient transplanted

Patient with a history of cancer or autoimmune disease within 5 years

Pregnant or lactating women

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
Intervention / Treatment
Hepatitis B infected patients or cured
blood samples are performed to measure active T cellular immune response during a routine visit
Biological: blood samples are performed to measure active T cellular immune response during a routine visit

During the visit 1 (V1), after signing the informed consent, 40 mL blood sampling are carried out and analyzed with the test ELISPOT to check if the patient shows a T immune response against HBV.

The visit 2 will be performed 4-8 weeks (depending on the availability of the patient) following V1 visit, in case the patient shows an immune response against HBV positive T following the sample taken at V1. 150 ml blood sampling are carried out at this visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of T cell response by hepatitis B antigen detected in at least one subject.
Time Frame: at day 1
The method is based on the ELISPOT test. The method measures the cytokine secretion associated with immune activation after stimulation of peripheral blood mononuclear cells
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
The probability of detection of a positive T cell response in a single measurement
Time Frame: at day 1
at day 1

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Fabien Zoulim, PU PH, Hopital de la Croix-Rousse

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

July 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0679

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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