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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Lyon、フランス、69004
- Hôpital de La Croix Rousse
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Hepatitis B infected patients or cured
blood samples are performed to measure active T cellular immune response during a routine visit
|
生物学的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measurement of T cell response by hepatitis B antigen detected in at least one subject.
時間枠：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
|
at day 1
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
The probability of detection of a positive T cell response in a single measurement
時間枠：at day 1
|
at day 1
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Fabien Zoulim, PU PH、Hôpital de la Croix-Rousse
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 69HCL15_0679
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