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The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL (KLL2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919321
First Posted: June 12, 2009
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Turku University Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
MSinisalo, Tampere University Hospital
  Purpose

Patients with chronic lymphocytic leukemia (CLL)have had very poor humoral responses to pneumococcal polysaccharide vaccine (PPV). The vaccine in which pneumococcal polysaccharide antigens are conjugated to protein (PCV) have been immunogenic in CLL patients in our previous studies.

The purpose of this study is to evaluate the duration of these vaccine-induced antibodies and the function of memory cells by giving a one dose of PPV-vaccine after several years of PCV-vaccination.


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL) Biological: Pneumococcal polysaccharide vaccine (PPV) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by MSinisalo, Tampere University Hospital:

Primary Outcome Measures:
  • Antibody response [ Time Frame: 1-3 months ]

Enrollment: 32
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PPV Biological: Pneumococcal polysaccharide vaccine (PPV)
One intramuscular injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • CLL patients and controls who have been vaccinated with PCV in our previous study

Exclusion Criteria:

  • Vaccinated with PPV-vaccine within the last 5 years, immunoglobulin substitution, corticosteroid treatment (equivalent of 20mg prednisolone per day)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919321


Locations
Finland
Tampere University Hospital
Tampere, Finland, FIN 33521
Sponsors and Collaborators
Tampere University Hospital
Turku University Hospital
National Institute for Health and Welfare, Finland
  More Information

Publications:
Responsible Party: MSinisalo, Dr, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00919321     History of Changes
Other Study ID Numbers: R09082M
2009-012099-29 ( EudraCT Number )
First Submitted: June 11, 2009
First Posted: June 12, 2009
Last Update Posted: February 19, 2014
Last Verified: March 2012

Keywords provided by MSinisalo, Tampere University Hospital:
CLL
PPV
PCV

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs