Pneumococcal Vaccine in Untreated CLL Patients

A Randomized Phase III Trial to Determine Whether Conjugated Pneumococcal Vaccine Can Improve the Immune Responsiveness Compared to Polyclonal Pneumococcal Vaccine in Patients With Untreated Chronic Lymphocytic Leukemia

The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms of immune response.

Inclusion Criteria:

• Untreated CLL patients all Rai stages (0 to IV), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and/or chemotherapy

Exclusion Criteria:

• Immunosuppressive therapy planned to start within 1 month
• Other malignancies
• Corticosteroids or other immunosuppressive drugs
• Previous allergic reaction to any vaccination in the past
• Neutropenia (PMNs < 500 cells/mm3)