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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04748185

Enrollment

358

Registered

2021-02-10

Start date

2021-01-28

Completion date

2022-07-13

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lymphoma, Covid-19 Vaccine, CLL

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 memory B cell ELISPOT response

Countries

United States

Outcome results