NCT04748185已完成不适用
Immunogenicity and Safety of Commercially Available Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients With Hematologic Malignancies and Associated Precursor Conditions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Humoral Immunogenicity
研究概览
简要总结
D1. Primary Objective:
- Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies
D2. Secondary Objectives:
- Assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies
- Analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination
- Compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA
- Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination
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
- •Patients must not have received any prior COVID-19 vaccination
- •Patients must have any one of the following diagnosis:
- •a. Monoclonal B-cell lymphocytosis b. Chronic lymphocytic leukemia/small lymphocytic lymphoma c. B-cell Non-Hodgkin's lymphoma: i. Follicular lymphoma ii. Mantle cell lymphoma iii. Diffuse large B-cell lymphoma iv. Marginal zone lymphoma v. Burkitt lymphoma vi. Double hit/triple hit lymphoma vii. Lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia d. Hodgkin lymphoma
排除标准
- •Receipt of any vaccination (e.g., influenza, recombinant zoster) 2 weeks prior to registration
- •Prior chemotherapy, immunotherapy or oral agent therapy that was completed >12 months prior to enrollment. NOTE: patients who are on oral agents for the treatment of their underlying malignancy will be allowed. Some of these medication classes include Bruton tyrosine kinase inhibitor (BTKi), BCL2 antagonists, PI3 kinase inhibitors, immunomodulatory agents, among others. Please contact the Principal Investigator for any clarification about these medications.
结局指标
主要结局
Humoral Immunogenicity
时间窗: Assessed 14 days following the second dose of the vaccine
Number of participants who have detectable antibodies to SARS-Co-V2 vaccination
Cellular Immunogenicity
时间窗: Assessed 14 days following the second dose of the vaccine
Number of participants who have a SARS-CoV-2 specific IFNγ ELISPOT T cell response
次要结局
未报告次要终点
研究者
研究点 (1)
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