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

Mayo Clinic

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04748185

20-012589

Details and patient eligibility

About

D1. Primary Objective:

1. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies

D2. Secondary Objectives:

1. Assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies
2. Analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination
3. Compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA
4. Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination

Enrollment: 358 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must not have received any prior COVID-19 vaccination

2. 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

1. Receipt of any vaccination (e.g., influenza, recombinant zoster) 2 weeks prior to registration
2. 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.