Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
- 试验地点
- 3
- 主要终点
- Anti-Spike-IgG titers
研究概览
简要总结
This multicenter, prospective, non-interventional study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in immunocompromised patients.
详细描述
This study aims to analyze the immune response data generated within the procedures of the standard-of-care COVID-19 vaccination. for immunocompromised patients.
Additional blood will be drawn from the patients at each visit defined within the vaccination standard by using the same vein puncture as used for blood drawings of routine blood samples. Study related blood samples will be used for evaluation of T and B cell response to COVID-19 vaccinations.
For this study, no additional visits or invasive procedures will be performed in addition to the standard interventions.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Anti-Spike-IgG titers
时间窗: At the end of each vaccination cycle (each cycle is 28 days)
Time to an adequate immune response according to the recent version of the COVID-19 vaccination standard after repeated mRNA vaccinations
次要结局
- BA.1-specific neutralizing antibody ID50 titers(At the end of each vaccination cycle (each cycle is 28 days))
- Decrease of BA.1-specific neutralizing antibody ID50 titers(Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks)
- Anti-Spike-1/2 IgG decrease ≤33.8 BAU/ml(Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks)
- Anti-Spike-1/2 IgG increase >33.8 BAU/ml(At the end of each vaccination cycle (each cycle is 28 days))
研究者
Oliver Cornely, MD
Principal Investigator
University of Cologne