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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04748185

Collaborator

(none)

2,300

Enrollment

Location

24.4

Anticipated Duration (Months)

94.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma B-cell Non Hodgkin Lymphoma Hodgkin Lymphoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

2300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 18, 2021

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jan 30, 2023

Outcome Measures

Primary Outcome Measures

Humoral Immunogenicity [Assessed 14 days following the second dose of the vaccine]
Number of participants who have detectable antibodies to SARS-Co-V2 vaccination
Cellular Immunogenicity [Assessed 14 days following the second dose of the vaccine]
Number of participants who have a SARS-CoV-2 specific memory B cell ELISPOT response
Cellular Immunogenicity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must not have received any prior COVID-19 vaccination
Patients must have any one of the following diagnosis:

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.