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Pneumococcal Vaccine in Untreated CLL Patients

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Prevenar 13
Pneumovax
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pneumovax

Prevenar 13

Arm Description

Pneumovax, 1x 0.5 ml injection

Prevenar 13, 1x 0.5 ml injection

Outcomes

Primary Outcome Measures

Immune response to Pneumovax compared to immune response to Prevenar

Secondary Outcome Measures

Serotype-specific immunoglobulin G (IgG) antibody levels
Immune response to Pneumovax vs. Prevenar13
Levels of opsonophagocytic antibodies (OPA)
Immune response
Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms

Full Information

First Posted
June 12, 2013
Last Updated
January 14, 2016
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01892618
Brief Title
Pneumococcal Vaccine in Untreated CLL Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pneumovax
Arm Type
Active Comparator
Arm Description
Pneumovax, 1x 0.5 ml injection
Arm Title
Prevenar 13
Arm Type
Experimental
Arm Description
Prevenar 13, 1x 0.5 ml injection
Intervention Type
Drug
Intervention Name(s)
Prevenar 13
Intervention Description
13-valent pneumococcal conjugated vaccine
Intervention Type
Drug
Intervention Name(s)
Pneumovax
Intervention Description
23-valent pneumococcal polysaccharide vaccine
Primary Outcome Measure Information:
Title
Immune response to Pneumovax compared to immune response to Prevenar
Time Frame
1 month post vaccination
Secondary Outcome Measure Information:
Title
Serotype-specific immunoglobulin G (IgG) antibody levels
Description
Immune response to Pneumovax vs. Prevenar13
Time Frame
1 and 6 months post vaccination
Title
Levels of opsonophagocytic antibodies (OPA)
Description
Immune response
Time Frame
6 months post vaccination
Title
Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms
Time Frame
1 and 6 months post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Kimby, Professor
Organizational Affiliation
Karolinska University Hospital, SE-141 86 Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

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Pneumococcal Vaccine in Untreated CLL Patients

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