Back to resultsThe Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL (KLL2)
Primary Purpose
Chronic Lymphocytic Leukemia (CLL)
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Pneumococcal polysaccharide vaccine (PPV)
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring CLL, PPV, PCV
Eligibility Criteria
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)
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PPV
Arm Description
Outcomes
Primary Outcome Measures
Antibody response
Secondary Outcome Measures
Full Information
NCT ID
NCT00919321
First Posted
June 11, 2009
Last Updated
February 17, 2014
Sponsor
Tampere University Hospital
Collaborators
Turku University Hospital, Finnish Institute for Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT00919321
Brief Title
The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL
Acronym
KLL2
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Turku University Hospital, Finnish Institute for Health and Welfare
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL)
Keywords
CLL, PPV, PCV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPV
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Pneumococcal polysaccharide vaccine (PPV)
Intervention Description
One intramuscular injection
Primary Outcome Measure Information:
Title
Antibody response
Time Frame
1-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
FIN 33521
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18053620
Citation
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.
Results Reference
background
PubMed Identifier
11472353
Citation
Sinisalo 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.
Results Reference
background
PubMed Identifier
29420116
Citation
Lindstrom 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.
Results Reference
derived
Learn more about this trial
The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL
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