Clinical trial NCT03350425: Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients
Official title: Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CKD (Chronic Kidney Disease) Stage 5D
Pneumonia
Keywords: hemodialysis
pneumococcal vaccination
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: German Center for Infection Research
First posted: 2017-11-22
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult hemodialysis patients vaccinated against pneumococcal infection or eligible and willing to be vaccinated

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).

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

Primary outcomes:
measure: Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago
timeFrame: 2 years
Secondary outcomes:
measure: Pneumococcal antibody kinetics as a function of time since vaccination.
timeFrame: 2 years
measure: Factors influencing antibody kinetics
timeFrame: 2 years
Other outcomes:
measure: Exploration of the relationship between anti-pneumococcal antibody titers and a possible cut-off for protection from pneumonia
timeFrame: 2 years
measure: Factors influencing pneumonia and vaccine response
timeFrame: 2 years
Locations:
city: Munich
country: Germany
facility: Hospital of the Ludwig-Maximilians-University (LMU)
state: Bavaria
city: Munich
country: Germany
facility: The University Hospital Klinikum rechts der Isar - MRI TUM
state: Bavaria
city: Tübingen
country: Germany
facility: Eberhard Karls University Tübingen
state: BW
city: Gießen
country: Germany
facility: University Hospital Giessen und Marburg, Giessen site
state: Hessen
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Hessen
city: Marburg
country: Germany
facility: University Hospital Giessen und Marburg, Marburg site
state: Hessen
city: Hannover
country: Germany
facility: Hannover Medical School
state: NI
city: Bonn
country: Germany
facility: University Hospital Bonn
state: NRW
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
city: Borstel
country: Germany
facility: Medical Clinic, Research Center Borstel
state: SH
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Lübeck
state: SH
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
affiliation: University of Cologne
name: Oliver A Cornely, MD
role: PRINCIPAL_INVESTIGATOR
References: