Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients with Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial

PRIMARY OBJECTIVE:

I. To investigate the proportion of chronic lymphocytic leukemia (CLL) patients who mount an effective immune response to streptococcus pneumonia after receiving both pneumococcal 20-valent conjugate vaccine (PCV20) and pneumococcal polyvalent vaccine (PPSV23) vaccinations. (Primary Analysis)

SECONDARY OBJECTIVES:

I. To improve the immunoglobulin levels and decrease the incidence of pneumonia in patients with CLL-associated immunodeficiency. (Primary Analysis)

II. To evaluate the rate of decreased pneumonia as assessed by an immune response to streptococcus (S.) pneumoniae after PCV20 and PPSV23 series versus PCV20 alone. (Primary Analysis)

III. To investigate the immune response to individual S. pneumoniae serotypes included in both the PCV20 and PPSV23 vaccinations. (Primary Analysis)

IV. Evaluate the length of time an effective immune response is maintained, and if the recommendation of 5 years is adequate for CLL patients. (Primary Analysis)

EXPLORATORY OBJECTIVES:

I. Assess rate of pneumonia in CLL patients based on therapeutic strategy (i.e., BTKi, venetoclax, chemo-immunotherapy).

II. To evaluate the number of venetoclax treated CLL patients who mount an effective immune response to S. pneumoniae 30 days following both PCV20 and PPSV23 vaccinations. (Pilot Arm)

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I (PRIMARY ARM): Patients receive pneumococcal 20-valent conjugate vaccine intramuscularly (IM) at visit 1 (day 1) and pneumococcal polyvalent vaccine IM at visit 2 (approximately day 75) in the absence of disease progression or unacceptable toxicity.

ARM II (PILOT ARM): Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at visit 1 (day 1) and pneumococcal polyvalent vaccine IM at visit 2 (approximately day 75) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 90 days and then every 6 months for 5 years.