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.
Turku University Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
MSinisalo, Tampere University Hospital Identifier:
First received: June 11, 2009
Last updated: February 17, 2014
Last verified: March 2012

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:

Further study details as provided by Tampere University Hospital:

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

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


Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00919321

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

Responsible Party: MSinisalo, Dr, Tampere University Hospital Identifier: NCT00919321     History of Changes
Other Study ID Numbers: R09082M  2009-012099-29 
Study First Received: June 11, 2009
Last Updated: February 17, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016