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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: blood samples are performed to measure active T cellular immune response during a routine visit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatitis B infected patients or cured<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of T cell response by hepatitis B antigen detected in at least one subject. | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| The probability of detection of a positive T cell response in a single measurement |  | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Virus, Elispot test, T cellular immune response