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

July 7, 2023 updated by: Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

358

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients will submit peripheral blood samples a) prior to first dose of vaccination; b) prior to receipt of the second dose of vaccination; c) 14 days following the second dose; and d) 3, 6 and 12 months following the first dose of the vaccination. For patients at time points a, b, and c blood samples can be collected up to 3 days prior; and at time point d +/- 10 days.

Patients who are seen at Mayo Clinic in Rochester, MN can collect their blood through a venipuncture at the clinic. For patients who are to receive vaccination locally, a blood kit will be mailed for the patients to get research bloods collected and sent to Mayo Clinic.

All patients will also complete a diary of adverse reactions (Appendix I) daily for 7 days after receipt of each dose of the vaccine. Patients will be asked to contact their primary care provider or hematologist if they have any side effects from the vaccination.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral Immunogenicity
Time Frame: Assessed 14 days following the second dose of the vaccine
Number of participants who have detectable antibodies to SARS-Co-V2 vaccination
Assessed 14 days following the second dose of the vaccine
Cellular Immunogenicity
Time Frame: 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
Assessed 14 days following the second dose of the vaccine
Cellular Immunogenicity
Time Frame: 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
Assessed 14 days following the second dose of the vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Sameer Parikh, M.B.B.S., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Actual)

July 13, 2022

Study Completion (Actual)

July 13, 2022

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-012589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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