Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
NCT ID: NCT02909023
Last Updated: 2016-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2016-07-31
2016-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hepatitis B infected patients or cured
blood samples are performed to measure active T cellular immune response during a routine visit
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Fabien Zoulim, PU PH
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la Croix-Rousse
Locations
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Hôpital de la Croix Rousse
Lyon, , France
Countries
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Other Identifiers
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69HCL15_0679
Identifier Type: -
Identifier Source: org_study_id