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 enrollmentAugust 2013

ConditionsChronic Lymphocytic Leukemia

InterventionsPneumovax Prevenar 13

DrugsPrevenar 13 Pneumovax

Overview

Phase: Phase 3
Intervention: Pneumovax
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Karolinska University Hospital
Enrollment: 134
Locations: 1
Primary Endpoint: Immune response to Pneumovax compared to immune response to Prevenar
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karolinska University Hospital

Responsible Party

Principal Investigator

Eva Kimby

Professor

Karolinska University Hospital

Eligibility 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)

Arms & Interventions

Pneumovax

Pneumovax, 1x 0.5 ml injection

Intervention: Pneumovax

Prevenar 13

Prevenar 13, 1x 0.5 ml injection

Intervention: Prevenar 13

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)