Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Lyon, 프랑스, 69004
- Hôpital de La Croix Rousse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Measurement of T cell response by hepatitis B antigen detected in at least one subject.
기간: at day 1
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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
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at day 1
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The probability of detection of a positive T cell response in a single measurement
기간: at day 1
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at day 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Fabien Zoulim, PU PH, Hôpital de la Croix-Rousse
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 69HCL15_0679
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