Clinical trial NCT04748185: Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients With Hematologic Malignancies
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monoclonal B-Cell Lymphocytosis
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
B-cell Non Hodgkin Lymphoma
Hodgkin Lymphoma
Keywords: Lymphoma
Covid-19 Vaccine
CLL
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Humoral Immunogenicity
timeFrame: Assessed 14 days following the second dose of the vaccine
measure: Cellular Immunogenicity
timeFrame: Assessed 14 days following the second dose of the vaccine
measure: Cellular Immunogenicity
timeFrame: Assessed 14 days following the second dose of the vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sameer Parikh, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References: