Immunization of immunosuppressed patients – Knowledge, practices and serological response

Phase 1

• Conditions: Immunoresponse on pneumococcal vaccination of kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease.; MedDRA version: 21.0Level: LLTClassification code 10076412Term: Chronic kidney disease stage 5System Organ Class: 100000004857; MedDRA version: 21.1Level: LLTClassification code 10069594Term: Pneumococcal immunizationSystem Organ Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-004123-23-DK
• Lead Sponsor: Department of Infectious Diseases, Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-10
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease.
Over 18 years old
Not pregnant
Patient in nefrology outpatient clinic at Odense University Hospital or Zealand University Hospital, Roskilde or University Hospital Hovedstaden, Rigshospitalet.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Hypersensitivity to Diphtheria toxoid, active substance or excipients in the vaccines.
Pneumovax vaccination within the last 12 months.
Refuses to be vaccinated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: A direct head to head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, for Prenevar 13 and Pneumovax, independently of the immunomodulatory therapy.<br>;Secondary Objective: A comparison of the pneumococcal antibody level pre and post vaccination (for Prenevar 13 and Pneumovax) in the different treatment groups (Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease).;Primary end point(s): The primary endpoint is a direct head-to-head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, independently of Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease.;Timepoint(s) of evaluation of this end point: December 2021

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint is a direct head-to-head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, dependent of Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease.;Timepoint(s) of evaluation of this end point: December 2021