Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

NCT03350425 | Completed

• 1 other identifier: DOPPIO
• Study Type: observational
• Target: 792
• Locations: 1 country
• Sites: 12

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.

Conditions

CKD (Chronic Kidney Disease) Stage 5D; Pneumonia

Keywords

hemodialysis; pneumococcal vaccination

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (2)

• Pneumococcal antibody kinetics as a function of time since vaccination.

  2 years

• Factors influencing antibody kinetics

  2 years

Other Outcomes (2)

• Exploration of the relationship between anti-pneumococcal antibody titers and a possible cut-off for protection from pneumonia

  2 years

• Factors influencing pneumonia and vaccine response

  2 years

Study Arms (2)

Recently vaccinated patients

Patients who recently received pneumococcal vaccination.

Patients vaccinated >2 years ago

Patients who received pneumococcal vaccination more than two years ago.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult hemodialysis patients vaccinated against pneumococcal infection or eligible and willing to be vaccinated

You may qualify if:

• 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

You may not qualify if:

• Patients unwilling/ineligible for vaccination under current STIKO recommendations

Sponsors & Collaborators

• University of Cologne: lead
• German Center for Infection Research: collaborator

Study Sites (12)

Eberhard Karls University Tübingen

Tübingen, Baden-Wurttemberg, 72074, Germany

Location

Hospital of the Ludwig-Maximilians-University (LMU)

Munich, Bavaria, 80336, Germany

Location

The University Hospital Klinikum rechts der Isar - MRI TUM

Munich, Bavaria, 81675, Germany

Location

University Hospital Giessen und Marburg, Giessen site

Giessen, Hesse, 35392, Germany

Location

University Hospital Heidelberg

Heidelberg, Hesse, 69120, Germany

Location

University Hospital Giessen und Marburg, Marburg site

Marburg, Hesse, 35043, Germany

Location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Medical Clinic, Research Center Borstel

Borstel, Schleswig-Holstein, 23845, Germany

Location

University Hospital Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 37436797 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be obtained for determination of pneumococcal antibody-titers every three months for two years. The samples will be taken on dialysis days and thus constitute only a minimal additional burden for both patients and physicians

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Pneumonia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oliver A Cornely, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: November 22, 2017
• Study Start: December 21, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

DE (12)