Status:
COMPLETED
Immune Response After Pneumococcal Vaccination in Patient With Chronic Lymphocytic Leukemia
Lead Sponsor:
Region Örebro County
Conditions:
CLL
Vaccine Response
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A randomized, multi-centre trial was conducted between 2013-2016, including 128 patients with untreated CLL from eight hematological clinics in Sweden. Vaccination with polysaccharide pneumococcal vac...
Detailed Description
Chronic lymphocytic leukemia (CLL) patients have increased risk of pneumococcal infection due to defect T-cells, complements and neutrophil/monocyte function or hypogammaglobulinaemia. Side effects of...
Eligibility Criteria
Inclusion
- CLL patients earlier included in the Pneumococcal vaccination study 0887x1-20003 (EudraCT No: 2009-012642-22), who have received either PCV13 or PPSV23 are eligible for evaluation
Exclusion
- Patients receiving high dose corticosteroids ( ≥20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment (criteria for inclusion after discontinuing high dose corticosteroid treatment, see section 7.3)
- Patients who have had an allergic reaction to any vaccination in the past
- Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP (immune thrombocytopenia) and Guillain-Barre
- Patients failing to give informed consent
- Patients with ongoing immunoglobulin therapy
- Patients with known HIV infection
- Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months
- Active febrile infection
- Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3) -
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05316831
Start Date
January 1 2019
End Date
October 1 2022
Last Update
March 30 2023
Active Locations (1)
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1
Magdalena Kättström
Örebro, Sweden