The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL
KLL2
2 other identifiers
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 19, 2014
March 1, 2012
4.5 years
June 11, 2009
February 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibody response
1-3 months
Study Arms (1)
PPV
OTHERInterventions
Eligibility Criteria
You may qualify if:
- CLL patients and controls who have been vaccinated with PCV in our previous study
You may not qualify if:
- Vaccinated with PPV-vaccine within the last 5 years, immunoglobulin substitution, corticosteroid treatment (equivalent of 20mg prednisolone per day)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Turku University Hospitalcollaborator
- Finnish Institute for Health and Welfarecollaborator
Study Sites (1)
Tampere University Hospital
Tampere, Pirkanmaa, FIN 33521, Finland
Related Publications (3)
Sinisalo M, Vilpo J, Itala M, Vakevainen 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. doi: 10.1016/j.vaccine.2007.10.053. Epub 2007 Nov 12.
PMID: 18053620BACKGROUNDSinisalo M, Aittoniemi J, Oivanen P, Kayhty 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. doi: 10.1046/j.1365-2141.2001.02882.x.
PMID: 11472353BACKGROUNDLindstrom V, Aittoniemi J, Salmenniemi U, Kayhty H, Huhtala H, Itala-Remes M, Sinisalo M. Antibody persistence after pneumococcal conjugate vaccination in patients with chronic lymphocytic leukemia. Hum Vaccin Immunother. 2018 Jun 3;14(6):1471-1474. doi: 10.1080/21645515.2018.1436424. Epub 2018 Feb 23.
PMID: 29420116DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 12, 2009
Study Start
June 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 19, 2014
Record last verified: 2012-03