Pneumococcal Vaccine in Untreated CLL Patients

Karolinska University Hospital134 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Chronic Lymphocytic Leukemia

Interventions

Prevenar 13DRUG

13-valent pneumococcal conjugated vaccine

PneumovaxDRUG

23-valent pneumococcal polysaccharide vaccine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

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

Immune response to Pneumovax vs. Prevenar13

Time frame: 1 and 6 months post vaccination

Levels of opsonophagocytic antibodies (OPA)

Immune response

Time frame: 6 months post vaccination

Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms

Time frame: 1 and 6 months post vaccination

Data from ClinicalTrials.gov

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