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

Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748185
• Other study ID #: 20-012589
• Status: Completed
• Start date: January 28, 2021
• Est. completion date: July 13, 2022

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Non Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Hematologic Neoplasms
• Hodgkin Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphocytosis
• Lymphoma
• Lymphoma, B-Cell
• Monoclonal B-Cell Lymphocytosis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral Immunogenicity	Number of participants who have detectable antibodies to SARS-Co-V2 vaccination	Assessed 14 days following the second dose of the vaccine
Primary	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
Primary	Cellular Immunogenicity	Number of participants who have a SARS-CoV-2 specific IFN? ELISPOT T cell response	Assessed 14 days following the second dose of the vaccine

External Links

•   Mayo Clinic Clinical Trials