The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

— KLL2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919321
• Other study ID #: R09082M
• Secondary ID: 2009-012099-29
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2009
• Last updated: February 17, 2014
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Biological:
• Pneumococcal polysaccharide vaccine (PPV)
One intramuscular injection

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	National Institute for Health and Welfare, Finland, Turku University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody response		1-3 months	Yes