Chronic Lymphocytic Leukemia (CLL) Clinical Trial
— KLL2Verified date | March 2012 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 45 Years to 90 Years |
Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital | National Institute for Health and Welfare, Finland, Turku University Hospital |
Finland,
Sinisalo M, Aittoniemi J, Oivanen P, Käyhty H, Olander RM, Vilpo J. Response to vaccination against different types of antigens in patients with chronic lymphocytic leukaemia. Br J Haematol. 2001 Jul;114(1):107-10. — View Citation
Sinisalo M, Vilpo J, Itälä M, Väkeväinen M, Taurio J, Aittoniemi J. Antibody response to 7-valent conjugated pneumococcal vaccine in patients with chronic lymphocytic leukaemia. Vaccine. 2007 Dec 21;26(1):82-7. Epub 2007 Nov 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody response | 1-3 months | Yes |
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