Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

Completed

• Conditions: CKD (Chronic Kidney Disease) Stage 5D; Pneumonia

• Registration Number: NCT03350425
• Lead Sponsor: University of Cologne

Brief Summary

The investigators 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 exploratory objectives, the investigators will describe the anti-pneumococcal antibody titers in hemodialysis patients as a function of time since vaccination, and determine factors influencing antibody kinetics. Further exploratory objectives investigate the relationship between antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolate a possible cut-off for protection from pneumonia.

Detailed Description

Participating sites will screen all hemodialysis patients at their outpatient dialysis clinic for eligibility. Eligible patients will be approached and informed by their treating physician. If a patient agrees to participate in the study and to sign an informed consent form, basic data regarding vaccination history, underlying disease, etc. will be entered or electronically imported into the study eCRF. Pneumococcal antibody titers will be drawn at baseline and every 3 months. For newly vaccinated patients baseline titers will be drawn 4 weeks after the vaccination. DZIF CTUs will coordinate titer assessment schedules and inform the participating physicians of upcoming blood samplings. The samples will be taken on dialysis days and thus constitute only a minimal additional burden for both patients and physicians. DZIF CTUs will actively follow up on study patients for 2 years after enrolment. This follow-up will include validation of all hospitalizations and deaths documented in an electronic registry database to assess whether the primary endpoint (pneumonia) occurred. Additionally, dialysis units will be contacted every 6 months to assess if pneumonia occurred, which did not require hospitalization. DZIF CTUs will document titer assessment results in the eCRF. Titers will not be disclosed to the attending physicians because revaccination due to knowledge of titers would produce bias. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (e.g. RKI STIKO recommendations).

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Study Start: 2017-12-21
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

Inclusion Criteria

• Signed informed consent form including enrolment in registry database (QiN-registry)
• Patients with stage 5 chronic kidney disease treated with chronic hemodialysis
• Patients who are either already vaccinated or eligible and willing to be vaccinated against pneumococcal infection in accordance with current STIKO recommendations
• Age of 18 years or older

Exclusion Criteria

• Patients unwilling/ineligible for vaccination under current STIKO recommendations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago	2 years

Secondary Outcome Measures

Name	Time	Method
Factors influencing antibody kinetics	2 years	Determination of factors influencing antibody kinetics (e.g. age, prior or ongoing immunosuppression, medication, prior vaccination history) by multiple multivariate models
Pneumococcal antibody kinetics as a function of time since vaccination.	2 years	Description of antibody titers in hemodialysis patients as a function of time since vaccination.

Trial Locations

Locations (12)

Eberhard Karls University Tübingen; 🇩🇪 Tübingen, BW, Germany

University Hospital Bonn; 🇩🇪 Bonn, NRW, Germany

Medical Clinic, Research Center Borstel; 🇩🇪 Borstel, SH, Germany

The University Hospital Klinikum rechts der Isar - MRI TUM; 🇩🇪 Munich, Bavaria, Germany

University Hospital Giessen und Marburg, Giessen site; 🇩🇪 Gießen, Hessen, Germany

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

University Hospital Giessen und Marburg, Marburg site; 🇩🇪 Marburg, Hessen, Germany

Hannover Medical School; 🇩🇪 Hannover, NI, Germany

University Hospital Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, SH, Germany

Hospital of the Ludwig-Maximilians-University (LMU); 🇩🇪 Munich, Bavaria, Germany

University Hospital Heidelberg; 🇩🇪 Heidelberg, Hessen, Germany

University Hospital Cologne; 🇩🇪 Cologne, NRW, Germany