Influenza Vaccination in Immunocompromized Patients

Phase 4

Completed

• Conditions: Immunosuppression
• Interventions: Biological: Virosomal influenza vaccine; Biological: Subunit influenza vaccine

• Registration Number: NCT00783380
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Evaluation of the immunogenicity and reactogenicity of two different formulations of commercially avail-able influenza vaccines in 4 different groups of immunocompromized outpatients (HIV positive patients, patients suffering from rheumatologic diseases and receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in immunocompromized patients in comparison to an older subunit formulation.

Detailed Description

The infection with influenza is associated with higher morbidity and mortality in risk groups including immunocompromized patients. The virosomal influenza vaccines have been associated with improved immunogenicity in former trials. No direct comparison with older formulations has been conducted so far.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-07
• Study Completion: 2008-03
• Status Verified: 2008-10
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Last Update Submitted: 2008-10-31
• Last Update Posted: 2008-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• Adult outpatients treated at the Inselspital Bern for:
• HIV infection
• rheumatologic diseases and receiving immunosuppressive drugs
• kidney transplant recipients
• undergoing hemodialysis or continuous ambulatory peritoneal dialysis
• written informed consent

Exclusion Criteria

• Allergy to egg proteins
• Former adverse reactions to prior vaccination
• Febrile conditions at the time of study inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virosomal influenza vaccine	Virosomal influenza vaccine	-
Subunit influenza vaccine	Subunit influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)	>60 Wochen

Secondary Outcome Measures

Name	Time	Method
Reactogenicity in rheumatologic patients by disease specific scores	Six weeks after vaccination
Immediate side effects at time of application of vaccination	Minutes after vaccination
Side effects after vaccination	First week after vaccination

Trial Locations

Locations (3)

Department of Rheumatic Diseases, Bern University Hospital; 🇨🇭 Bern, Switzerland

Department of Infectious Diseases, Bern University Hospital; 🇨🇭 Bern, Switzerland

Department of Nephrology/Hypertension, Bern University Hospital; 🇨🇭 Bern, Switzerland