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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital

Tampere, Pirkanmaa, FIN 33521, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pneumococcal polysaccharide vaccine (PPV)

Biological

One intramuscular injection

Primary outcomes

Antibody response

Time frame: 1-3 months

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

Finnish Institute for Health and Welfare
Turku University Hospital

Registry information

Acronym: KLL2

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Jun 12, 2009
Registry last updated: Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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