ong term effect on immune response after pneumococcal vaccination in patients with chronic lymphocytic leukemia and evaluation of the effect of revaccination.
- Conditions
- The aim of the study is to evaluate pneumococcal vaccination strategy with PPSV23 and PCV13 in patients with chronic lymphocytic leukemia (CLL) initially randomized in a clinical study.Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2018-003377-97-SE
- Lead Sponsor
- Swedish CLL-group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 126
CLL patients
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 of the long-term immune response. The median age of the patient group was at inclusion 70 years (range 46-87) with an equal number men and women (65/63). The same patients are eligible for revaccination if they do not meet any exclusion criteria. Ongoing or recent CLL specific treatment is not an exclusion criteria.
Controls
A control group (n=40) of immunocompetent subjects will be recruited in Region Örebro County. The control group will be matched to the CLL group by age and gender. For inclusion they should have been vaccinated with either PCV13 (n=20) or PPSV23 (n=20) approximately 3-5 years ago and not meet any exclusion criteria. They will subsequently be eligible for long-term immune response and revaccination according to the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
CLL patients
1.Patients receiving high dose corticosteroids ( =20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment
2.Patients who have had an allergic reaction to any vaccination in the past
3.Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP and Guillain-Barre
4.Patients failing to give informed consent
5.Patients with ongoing immunoglobulin therapy
6.Patients with known HIV infection
7.Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months
8.Active febrile infection
9.Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection
Controls
1.Serious chronic disorder including chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen treatment, end-stage renal disease, clinically unstable cardiac disease or any other disorder that, in the investigator’s opinion, excludes the subject from participating in the study;
2.Known or suspected immunodeficiency or other conditions associated with immunosuppression including immunoglobulin class/subclass deficiencies with or without substitution treatment, splenectomy in the medical history, generalized malignancy, human immunodeficiency virus (HIV) infection, haematological malignancies, bone marrow or organ transplant in the medical history;
3.Subjects receiving treatment with high dose corticosteroids (=20 mg Prednisolone) or other immunosuppressive drugs, or planned to receive through study participation;
4.Subjects who have had an allergic reaction to any component of PCV13 in the past;
5.Subjects with known present or previous hemolysis, ITP and Guillain-Barre;
6.Subjects failing to give informed consent;
7.Subjects who have received a pneumococcal vaccine after the primary vaccination aproximately 3-5 years ago;
8.Active febrile infection;
1.9.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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method