Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients With Hematologic Malignancies

Study Overview
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Brief Summary
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D1. Primary Objective: 1. 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

Official Title
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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

Conditions
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Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, B-cell Non Hodgkin Lymphoma, Hodgkin Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral Immunogenicity | Number of participants who have detectable antibodies to SARS-Co-V2 vaccination | Assessed 14 days following the second dose of the vaccine | 
| Cellular Immunogenicity | Number of participants who have a SARS-CoV-2 specific memory B cell ELISPOT response | Assessed 14 days following the second dose of the vaccine | 
| Cellular Immunogenicity | Number of participants who have a SARS-CoV-2 specific IFNγ ELISPOT T cell response | Assessed 14 days following the second dose of the vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Covid-19 Vaccine, CLL