Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

NCT ID: NCT03350425

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 792 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2022-12-31

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).

Conditions

CKD (Chronic Kidney Disease) Stage 5D; Pneumonia

Keywords

hemodialysis; pneumococcal vaccination

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Recently vaccinated patients

Patients who recently received pneumococcal vaccination.

No interventions assigned to this group

Patients vaccinated >2 years ago

Patients who received pneumococcal vaccination more than two years ago.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Center for Infection Research

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Oliver Cornely, MD

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver A Cornely, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

Eberhard Karls University Tübingen

Tübingen, Baden-Wurttemberg, Germany

Hospital of the Ludwig-Maximilians-University (LMU)

Munich, Bavaria, Germany

The University Hospital Klinikum rechts der Isar - MRI TUM

Munich, Bavaria, Germany

University Hospital Giessen und Marburg, Giessen site

Giessen, Hesse, Germany

University Hospital Heidelberg

Heidelberg, Hesse, Germany

University Hospital Giessen und Marburg, Marburg site

Marburg, Hesse, Germany

Hannover Medical School

Hanover, Lower Saxony, Germany

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Medical Clinic, Research Center Borstel

Borstel, Schleswig-Holstein, Germany

University Hospital Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

University Hospital Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

Mellinghoff S, von Gersdorff G, Bruns C, Albus K, Dimitriou V, Steinbach A, Schaller M, Vehreschild JJ, Cornely OA, Liss BJ. Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients (DOPPIO): Protocol for a Prospective Multicenter Study. JMIR Res Protoc. 2023 Jul 12;12:e45712. doi: 10.2196/45712.

Reference Type: DERIVED

PMID: 37436797 (View on PubMed)

Other Identifiers

DOPPIO

Identifier Type: -

Identifier Source: org_study_id