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

NCT04748185 | Completed DMC

• 1 other identifier: 20-012589
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

D1. Primary Objective: 1\. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies D2. Secondary Objectives:

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

Conditions

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

Keywords

Lymphoma; Covid-19 Vaccine; CLL

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell; Hodgkin Disease; Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin

Study Officials

• Sameer Parikh, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 10, 2021
• Study Start: January 28, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)