Advanced chronic kidney disease (CKD) is among the most common chronic health conditions in Germany. CKD 5D patients (CKD stage five with indication for dialysis) have a weakened immune system and are highly susceptible to infections. Pneumococcal pneumonia is one of the most frequent causes of death, even in vaccinated patients. Reasons for a reduced vaccination effect in this patient group remain elusive. The multicenter observational study DOPPIO is investigating the vaccination response of dialysis patients with the aim of improving individualized vaccination strategies.
Chronic diseases are among the leading causes of morbidity, mortality and increased costs in the German healthcare system. Infectious diseases in chronically ill patients remain a major challenge. Many complications caused by infections can be avoided by vaccination. Pneumonia is a leading cause of death in patients with end-stage chronic kidney disease (stage 5) treated with dialysis (CKD 5D). For these patients, the Robert Koch Institute recommends vaccination against pneumococcus, a pathogen that causes pneumonia, every six years. However, some studies call the current recommendation into question, as a decrease in protective antibodies was observed in this patient group well before the end of the 6-year period. For this reason, further studies in this field are necessary.
The DOPPIO study is conducted in collaboration with the Kuratorium für Dialyse und Nierentransplantation e.V. (KfH), a non-profit organization with access to more than 18,500 hemodialysis patients in 200 affiliated outpatient kidney centers throughout Germany. DOPPIO is linked with the KfH’s "Quality in Nephrology" (QiN) register, one of the largest quality programs for chronically ill patients in the German and European health care systems. The study is investigating the incidence of pneumonia and the antibody titres of recently vaccinated patients compared to patients whose last pneumococcal vaccination was more than two years ago.
Study patients are recruited in the dialysis practices of the KfH, while the DZIF clinical trial units (CTUs) coordinate the analysis of the blood samples and carry out the two-year follow-up for the occurrence of pneumonia. Recruitment started in December 2017 and 884 patients are expected to be enrolled by the end of May 2019. Even at this stage, a significant improvement in the vaccination rate is seen simply by conducting DOPPIO and thus raising patient awareness for vaccination: ~85% of the patients enrolled are vaccinated shortly before enrolment, many of them for the first time. The study should therefore not only lead to better protection against pneumococcal infections in this patient group, but also improve awareness of the importance of vaccinations for chronically ill patients.