Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia

Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia

Assessment of SARS-CoV2 (mRNA and adenovirus-based vaccines) and Conjugated Pneumococcal (PCV13) in Patients with Chronic Lymphocytic Leukemia

Inclusion/Exclusion Criteria:

• Age >18 years.

• Diagnosis of CLL or SLL according to WHO criteria.

• For patients receiving BTK inhibitor (Cohorts 1 and 2):

  • Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
  • Patient must have no known clinical or radiographic evidence of CLL progression.

• For patients not on active therapy (Cohort 3):

  • Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
  • The treating investigator must have no intention to initiate CLL therapy within 2 months.

• Patients must have not received PCV13 within 2 years. For patients with PCV13 within 5 years, S. pneumonia IgG antibody concentrations must be less than the reference value for at least 50% of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,19F and 23F. Patients can have received prior PPV23 within any time frame.

• Patient must have no known history of HIV or primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication (e.g. steroids, methotrexate, etc.).