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

Civil Hospices of Lyon

Status: Completed

Conditions: Hepatitis B

Treatments: Biological: blood samples are performed to measure active T cellular immune response during a routine visit

Study type: Observational

Funder types: Other

Identifiers

NCT02909023

69HCL15_0679

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 1 patient group

Hepatitis B infected patients or cured

Description:

blood samples are performed to measure active T cellular immune response during a routine visit

Treatment:

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