Pneumococcal Vaccine in Untreated CLL Patients

Karolinska University Hospital

Status and phase: Completed; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Pneumovax; Drug: Prevenar 13

Study type: Interventional

Funder types: Other

Identifiers

NCT01892618

2009-012642-22

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Pneumovax

Active Comparator group

Description:

Pneumovax, 1x 0.5 ml injection

Treatment:

Drug: Pneumovax

Prevenar 13

Experimental group

Description:

Prevenar 13, 1x 0.5 ml injection

Treatment:

Drug: Prevenar 13