JMIR Publications

ABSTRACT

Background:

Pneumonia is a leading cause of death in patients with end-stage chronic kidney disease treated with dialysis. Current vaccination schedules recommend pneumococcal vaccination to these patients every 6 years. However, these disregard findings of rapid titre decline in adult haemodialysis patients after 6 to 12 months.

Objective:

We thus compare two strata of vaccinated patients: those recently vaccinated and those vaccinated more than two years ago. The primary objective is to compare pneumonia rates between the groups. As an exploratory objective, anti-pneumococcal antibody titres in haemodialysis patients will be determined as a function of time since vaccination. Factors influencing antibody kinetics will be identified. In addition, the relationship between antibody titres and the incidence of pneumonia in haemodialysis patients will be investigated and a possible cut-off for protection from pneumonia extrapolated.

Methods:

Within this prospective multi-centre study, a total of 792 patients will be enrolled. A total of 12 partner sites (within the German Centre for Infection Research, DZIF) with allocated dialysis practices participate in this study. All dialysis patients who are vaccinated against pneumococcal infection in accordance with Robert Koch Institute (RKI) guidelines prior to enrolment will be eligible. Data on baseline demographics, vaccination history, and underlying disease will be assessed. Pneumococcal antibody titres will be determined at baseline and every 3 months for 2 years. For newly vaccinated patients, baseline titres will be obtained 4 weeks after the vaccination. DZIF Clinical Trial Units coordinate titre assessment schedules and active follow-up on study patients for 2,5 years after enrolment, including validation of endpoints of hospitalization, pneumonia, and death. Diagnostics and treatments including vaccinations will be administered as part of clinical routine and as recommended by appropriate guidelines (e.g., RKI recommendations).

Results:

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Conclusions:

This prospective study will increase physician adherence to current recommendations. Establishing a framework for the efficient evaluation of guideline recommendations through a combination of routine and study data will inform the evidence base for future guidelines.