NCT01892618CompletedPhase 3
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
Karolinska University Hospital1 site in 1 country134 target enrollmentStarted: August 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Immune response to Pneumovax compared to immune response to Prevenar
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Pneumovax
Active Comparator
Pneumovax, 1x 0.5 ml injection
Intervention: Pneumovax (Drug)
Prevenar 13
Experimental
Prevenar 13, 1x 0.5 ml injection
Intervention: Prevenar 13 (Drug)
Outcomes
Primary Outcomes
Immune response to Pneumovax compared to immune response to Prevenar
Time Frame: 1 month post vaccination
Secondary Outcomes
- Serotype-specific immunoglobulin G (IgG) antibody levels(1 and 6 months post vaccination)
- Levels of opsonophagocytic antibodies (OPA)(6 months post vaccination)
- Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms(1 and 6 months post vaccination)
Investigators
Eva Kimby
Professor
Karolinska University Hospital
Study Sites (1)
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