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

Completed

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

• Registration Number: NCT04748185
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 IFNγ ELISPOT T cell response

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States