CompletedNot Applicable

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

United States358 participantsStarted 2021-01-28

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must not have received any prior COVID-19 vaccination
✓. Patients must have any one of the following diagnosis:

Exclusion criteria

✕. 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.

What they're measuring

Humoral Immunogenicity

Timeframe: Assessed 14 days following the second dose of the vaccine

Cellular Immunogenicity

Timeframe: Assessed 14 days following the second dose of the vaccine

Cellular Immunogenicity

Timeframe: Assessed 14 days following the second dose of the vaccine

Trial details

NCT IDNCT04748185

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-07-13

View on ClinicalTrials.gov More Monoclonal B-Cell Lymphocytosis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must not have received any prior COVID-19 vaccination
✓. Patients must have any one of the following diagnosis:

Exclusion criteria

✕. 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.