Performance of the Hepatitis B Virus (HBV) ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Measurement of T cell response by hepatitis B antigen detected in at least one subject.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Measurement of T cell response by hepatitis B antigen detected in at least one subject.
时间窗: 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
次要结局
- The probability of detection of a positive T cell response in a single measurement(at day 1)