Pneumococcal Vaccine in Untreated CLL Patients

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine; Vaccines

Criteria

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)