Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Turku University Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
MSinisalo, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT00919321
First received: June 11, 2009
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Antibody response [ Time Frame: 1-3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PPV Biological: Pneumococcal polysaccharide vaccine (PPV)
One intramuscular injection

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 11, 2009
Last Updated: March 29, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:
CLL
PPV
PCV

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013