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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)

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ClinicalTrials.gov Identifier: NCT00919321
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : February 19, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Biological: Pneumococcal polysaccharide vaccine (PPV) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013


Arms and Interventions

Arm Intervention/treatment
PPV Biological: Pneumococcal polysaccharide vaccine (PPV)
One intramuscular injection


Outcome Measures

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

Eligibility Criteria

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 Posted: June 12, 2009    Key Record Dates
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