Pneumococcal Vaccine in Untreated CLL Patients

January 14, 2016 updated by: Eva Kimby, Karolinska University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pneumovax
Pneumovax, 1x 0.5 ml injection
Drug: Pneumovax
23-valent pneumococcal polysaccharide vaccine
Experimental: Prevenar 13
Prevenar 13, 1x 0.5 ml injection
Drug: Prevenar 13
13-valent pneumococcal conjugated vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune response to Pneumovax compared to immune response to Prevenar
Time Frame: 1 month post vaccination
1 month post vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype-specific immunoglobulin G (IgG) antibody levels
Time Frame: 1 and 6 months post vaccination
Immune response to Pneumovax vs. Prevenar13
1 and 6 months post vaccination
Levels of opsonophagocytic antibodies (OPA)
Time Frame: 6 months post vaccination
Immune response
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
1 and 6 months post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Eva Kimby, Professor, Karolinska University Hospital, SE-141 86 Stockholm, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimate)

July 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-012642-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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