Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

Pneumonia Clinical Trial

— DOPPIO  

Official title:

Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03350425
• Other study ID #: DOPPIO
• Status: Active, not recruiting
• Start date: December 21, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2019
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 792
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CKD (Chronic Kidney Disease) Stage 5D
• Kidney Diseases
• Pneumonia
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn	NRW
Germany	Medical Clinic, Research Center Borstel	Borstel	SH
Germany	University Hospital Cologne	Cologne	NRW
Germany	University Hospital Giessen und Marburg, Giessen site	Gießen	Hessen
Germany	University Hospital Hamburg-Eppendorf	Hamburg
Germany	Hannover Medical School	Hannover	NI
Germany	University Hospital Heidelberg	Heidelberg	Hessen
Germany	University Hospital Schleswig-Holstein, Campus Lübeck	Lübeck	SH
Germany	University Hospital Giessen und Marburg, Marburg site	Marburg	Hessen
Germany	Hospital of the Ludwig-Maximilians-University (LMU)	Munich	Bavaria
Germany	The University Hospital Klinikum rechts der Isar - MRI TUM	Munich	Bavaria
Germany	Eberhard Karls University Tübingen	Tübingen	BW

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	German Center for Infection Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago		2 years
Secondary	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
Secondary	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