Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Effective immune response (EIR) to PCV13 vaccination
研究概览
简要总结
Assessment of SARS-CoV2 (mRNA and adenovirus-based vaccines) and Conjugated Pneumococcal (PCV13) in Patients with Chronic Lymphocytic Leukemia
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
- •Age >18 years.
- •Diagnosis of CLL or SLL according to WHO criteria.
- •For patients receiving BTK inhibitor (Cohorts 1 and 2):
- •Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
- •Patient must have no known clinical or radiographic evidence of CLL progression.
- •For patients not on active therapy (Cohort 3):
- •Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
- •The treating investigator must have no intention to initiate CLL therapy within 2 months.
- •Patients must have not received PCV13 within 2 years. For patients with PCV13 within 5 years, S. pneumonia IgG antibody concentrations must be less than the reference value for at least 50% of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,19F and 23F. Patients can have received prior PPV23 within any time frame.
- •Patient must have no known history of HIV or primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication (e.g. steroids, methotrexate, etc.).
结局指标
主要结局
Effective immune response (EIR) to PCV13 vaccination
时间窗: 35 days (+/- 14 days) after vaccination
EIR is defined as a \>2-fold increase or conversion from a nonprotective to a protective titer for \>50% of specific S. pneumonia IgG titers (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) vs baseline.
Effective immune response (EIR) to COVID19 vaccination
时间窗: 35 days (+/- 14 days) after vaccination
EIR is defined as a \>4-fold increase from baseline, or seroconversion defined as change from negative to within the measuring interval, for specific SARS-CoV-2 antibody titers (spike protein). For patients without pre-COVID-19 vaccination. serology, a negative post-COVID-19 vaccination nucleocapsid antibody titer will be used as a surrogate for no prior infection and in this case a post-COVID-19 vaccination spike antibody titer within the measuring interval will be interpreted as an EIR.
次要结局
未报告次要终点
研究者
Jacob Soumerai, MD
Assistant Professor of Medicine, Clinical Investigator in Lymphoma
Massachusetts General Hospital