Randomiserad fas III-studie för att bestämma om konjugerat pneumokockvaccin kan förbättra immunsvar och leda till färre infektioner i jämförelse med polysackarid pneumokockvaccin hos patienter med obehandlad lymfatisk leukemi (KLL).

Phase 1

• Conditions: The purpose of the study is to determine wheter patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with conjugated pneumococcal vaccine compared to conventional 23-valent capsular polysaccarid vaccine in terms of immune response and infections.; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2009-012642-22-SE
• Lead Sponsor: Swedish CLL-group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-19
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Untreated CLL patients all Rai stages (0 to IV), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and /or chemotherapy.

Extension study:
CLL patients earlier included in the Pneumococcal vaccination study, who have received either PPSV23 or PCV13 and who have not received any additional pneumococcal vaccine outside the study protocol after 2013-2016 are eligible for analysis of the long-term immune response. 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.
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 31
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

Patients for whom immunosuppressive therapy is planned to start within one month.
• Patients with other malignancies
• Patients receiving corticosteroids or other immunosuppressive drugs
• Patients who have had an allergic reaction to any vaccination in the past
• Patients with neutropenia (PMNs < 500 cells/mm3)
• Patients with a positive DAT (Direct Antiglobulin Test) or known previous hemolysis
• Patients failing to give informed consent.
• Patients with ongoing immunoglobulin therapy
• Patients with known HIV infection
• Patients who have previously received pneumococcal vaccine within 5 years
• Active infection

Extension study:
• Patients receiving high dose corticosteroids or other immunosuppressive drugs that is not part of active CLL treatment
• 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 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 after the study vaccine was given.
• Active infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified