PRIMARY OBJECTIVE:~I. Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year) at 2 years (Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the enzyme-linked immunosorbent assay [ELISA] method).~SECONDARY OBJECTIVES:~I. Number of patients with anti-pneumococcal immunogenicity at 5 years. II. Number of patients with local and/or general reaction at months 1, 3 as self-reported.~III. Number of pneumococcal infections.~OUTLINE: Patients are randomized to 1 of 2 arms.~ARM A: Patients receive pneumococcal 13-valent conjugate vaccine (PCV13) intramuscularly (IM) at week 1 and pneumococcal polyvalent vaccine (PSV23) IM at week 8. Patients then receive PSV23 IM booster at years 1, 2, 3, 4 and 5.~ARM B: Patients receive PCV13 IM at week 1 and PSV23 IM at week 8. Patients then receive PSV23 IM booster at year 5.
This phase II trial compares the effect of initial vaccination (PCV13 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Current vaccination schedule for chronic lymphocytic leukemia patients is based on general recommendations in immunocompromised patients (initial vaccination with PCV13 followed by one dose of PSV23 after an interval of two months, followed by revaccination at 5 years). Giving patients frequent immunization as compared to 5 year immunization may result in higher protective titers in patients.