Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients (DOPPIO)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 792

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Hospital Hamburg-Eppendorf
  • BW
    • Tübingen, BW, Germany, 72074
      • Eberhard Karls University Tubingen
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Hospital of the Ludwig-Maximilians-University (LMU)
    • Munich, Bavaria, Germany, 81675
      • The University Hospital Klinikum rechts der Isar - MRI TUM
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • University Hospital Giessen und Marburg, Giessen site
    • Heidelberg, Hessen, Germany, 69120
      • University Hospital Heidelberg
    • Marburg, Hessen, Germany, 35043
      • University Hospital Giessen und Marburg, Marburg site
  • NI
    • Hannover, NI, Germany, 30625
      • Hannover Medical School
  • NRW
    • Bonn, NRW, Germany, 53127
      • University Hospital Bonn
    • Cologne, NRW, Germany, 50937
      • University Hospital Cologne
  • SH
    • Borstel, SH, Germany, 23845
      • Medical Clinic, Research Center Borstel
    • Lübeck, SH, Germany, 23562
      • University Hospital Schleswig-Holstein, Campus Lübeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Recently vaccinated patients; Patients who recently received pneumococcal vaccination.
Patients vaccinated >2 years ago; Patients who received pneumococcal vaccination more than two years ago.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploration of the relationship between anti-pneumococcal antibody titers and a possible cut-off for protection from pneumonia	Exploration of the relationship between anti-pneumococcal antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolation of a possible cut-off for protection from pneumonia.	2 years
Factors influencing pneumonia and vaccine response	Evaluation of role of patient history (e.g. underlying kidney disease) and clinical course (e.g. prior hospitalizations) on pneumonia and vaccine response.	2 years

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: German Center for Infection Research

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: hemodialysis; pneumococcal vaccination
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Pneumonia
• Other Study ID Numbers: DOPPIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No