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

Mass immunization campaigns are underway in the US after the emergency use authorization of highly effective vaccines against SARS-CoV-2. Despite the efficacy of these measures, patients with B cell malignancies and associated precursor conditions remain at a high risk of adverse outcomes due to COVID-19 infection. These patients were excluded from pivotal vaccination trials that tested the efficacy in the general population. Historically, patients with hematologic malignancies have a 20-50% rate of immunogenicity to routine vaccinations – either due to the underlying malignancy itself or due to immunosuppressive therapies. We are currently enrolling patients in an observational study (NCT04748185) to assess the immunogenicity and safety of commercially available vaccines against SARS-CoV-2 in patients with B cell malignancies and associated precursor conditions such as monoclonal B cell lymphocytosis (MBL). Eligible patients who those with a diagnosis of a B cell malignancy (without regard to treatment status of the underlying malignancy). In collaboration with the Mayo Vaccine Center, we will determine immunogenicity of SARS-CoV-2 vaccination by: a) measuring antibody response (including anti-spike antibody, anti-nucleocapsid antibody, and blocking antibody titers); and b) measuring cell mediated immune response (including T cell ELISpot assay).