Pneumococcal Vaccine in Untreated CLL Patients
Phase 3
Completed
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Drug: PneumovaxDrug: Prevenar 13
- Registration Number
- NCT01892618
- Lead Sponsor
- Karolinska University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pneumovax Pneumovax Pneumovax, 1x 0.5 ml injection Prevenar 13 Prevenar 13 Prevenar 13, 1x 0.5 ml injection
- Primary Outcome Measures
Name Time Method Immune response to Pneumovax compared to immune response to Prevenar 1 month post vaccination
- Secondary Outcome Measures
Name Time Method Serotype-specific immunoglobulin G (IgG) antibody levels 1 and 6 months post vaccination Immune response to Pneumovax vs. Prevenar13
Levels of opsonophagocytic antibodies (OPA) 6 months post vaccination Immune response
Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms 1 and 6 months post vaccination
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden