AN EXPLORATORY FOLLOW-UP STUDY OF LONG TERM ANTI-TELOMERASE IMMUNE RESPONSE AFTER INVAC-1 VACCINATION IN PATIENTS WITH LONG TERM SURVIVAL. Addendum to INVAC1-CT-101 PROTOCOL - EUDRACT NUMBER : 2013-004369-15
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Invectys
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- long term anti telomerase specific memory responses
研究概览
简要总结
This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).
详细描述
The primary goal of the study is to analyze anti-telomerase specific memory responses in blood of long term survival patients and to correlate these immune responses to their subsequent treatment since the end of INVAC1-CT-101 phase I study. Six patients are expected to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients who participated in the phase I study and are still alive at the present time
- •Ability to provide written informed consent and to understand and comply with the requirements of the study.
排除标准
- •Anemia (Hgb < 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique
- •Systolic blood pressure below 90 mm Hg
研究组 & 干预措施
INVAC-1
All patients have been treated by INVAC-1 vaccine during the previous phase 1 NCT02301754. No new treatment injection is required in this study.
干预措施: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study. (Drug)
结局指标
主要结局
long term anti telomerase specific memory responses
时间窗: 1 day visit
will be measured by ELISPOT on blood of patients who were treated by INVAC-1 in the phase I NCT02301754 study and are still alive at the present time
次要结局
未报告次要终点