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:
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: February 17, 2014
Last verified: March 2012

June 11, 2009
February 17, 2014
June 2009
December 2013   (final data collection date for primary outcome measure)
Antibody response [ Time Frame: 1-3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00919321 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Chronic Lymphocytic Leukemia (CLL)
Biological: Pneumococcal polysaccharide vaccine (PPV)
One intramuscular injection
PPV
Intervention: Biological: Pneumococcal polysaccharide vaccine (PPV)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
45 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00919321
R09082M, 2009-012099-29
No
MSinisalo, Tampere University Hospital
Tampere University Hospital
  • Turku University Hospital
  • National Institute for Health and Welfare, Finland
Not Provided
Tampere University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP