drugset / Trial / NCT05316831

Immune Response After Pneumococcal Vaccination in Patient With Chronic Lymphocytic Leukemia

NCT05316831

Phase 4 Completed 77 enrolled Region Örebro County
Non-randomizedParallel-groupOpen-labelPrevention

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 vaccine (PPSV23) or conjugated pneumococcal vaccine (PCV13) was performed and the results were published 2018. PCV13 showed a superior immune response, measured as OPA (opsonophagocytic assays) and ELISA (enzyme-linked immunosorbent assay), compared to PPSV23. Immune cells analyses after primary immunization will be performed. Between 2019-2021 a prospective follow up study was conducted of the same cohort and also included a control group. The study participants have been revaccinated with pneumococcal vaccines with the aim to evaluate the effect of repeated dose of PCV13. The antibody response (measured as titer with FMIA (fluorescent multiplexed bead-based immunoassay) and antibody function with MOPA (multiplexed opsonophagocytic assay) will be performed. Studies investigating the dynamics of immune cells before and after primary immunization and revaccination will be performed. The study will give important answers about the optimal vaccination strategy in patients with CLL and can improve the vaccination recommendations in immunocompromised patients.

Timeline

Start
2019-01-01
Primary completion
2021-06-30
Completion
2022-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pneumovax 23 Vaccine
Subject Prevnar 13 Vaccine