KLL2: The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL
Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00919321
Collaborator
Turku University Hospital (Other), Finnish Institute for Health and Welfare (Other)
32
1
1
54
0.6
Study Details
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 |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Study Start Date
:
Jun 1, 2009
Actual Primary Completion Date
:
Dec 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: PPV
|
Biological: Pneumococcal polysaccharide vaccine (PPV)
One intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Antibody response [1-3 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 90 Years
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tampere University Hospital | Tampere | Finland | FIN 33521 |
Sponsors and Collaborators
- Tampere University Hospital
- Turku University Hospital
- Finnish Institute for Health and Welfare
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
MSinisalo,
Dr,
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT00919321
Other Study ID Numbers:
- R09082M
- 2009-012099-29
First Posted:
Jun 12, 2009
Last Update Posted:
Feb 19, 2014
Last Verified:
Mar 1, 2012
Keywords provided by MSinisalo,
Dr,
Tampere University Hospital
Additional relevant MeSH terms: