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

Completed

• Conditions: Hepatitis B
• Interventions: Biological: blood samples are performed to measure active T cellular immune response during a routine visit

• Registration Number: NCT02909023
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Study Completion: 2016-11
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
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

Primary Outcome Measures

Name	Time	Method
Measurement of T cell response by hepatitis B antigen detected in at least one subject.	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

Secondary Outcome Measures

Name	Time	Method
The probability of detection of a positive T cell response in a single measurement	at day 1

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France