Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators.
研究概览
简要总结
On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Diagnosis of CLL was according to the IWCLL criteria
- •All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).
排除标准
- •previous covid19 virus infection
结局指标
主要结局
Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators.
时间窗: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
Answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire on the same clinic visit when blood is drawn for serologic tests.
Antibody Persistence after Third Dose of BNT162b2 mRNA COVID-19 Vaccination in Serongative Patients with Chronic Lymphocytic Leukemia
时间窗: 6 months
To study the efficacy of booster vaccine in patients with CLL who are seronegative after first 2 vaccines
次要结局
- Change in the immune response to BNT162b2 mRNA vaccine assessed on the basis of anti covid-19 IgG levels.(2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination)
研究者
tamar.tadmor
HEAD OF HEMATOLOGY
Bnai Zion Medical Center