Clinical trial NCT00783380: Influenza Vaccination in Immunocompromized Patients
Official title: Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immunosuppression
Keywords: Influenza vaccination
Subunit
Virosomal
HIV/AIDS
Renal Dialysis
Kidney transplantation
Rheumatologic diseases
Immunogenicity
Reactogenicity
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Abbott
name: Merck Sharp & Dohme LLC
name: Solvay Pharmaceuticals
First posted: 2008-10-31
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)
timeFrame: >60 Wochen
Secondary outcomes:
measure: Reactogenicity in rheumatologic patients by disease specific scores
timeFrame: Six weeks after vaccination
measure: Immediate side effects at time of application of vaccination
timeFrame: Minutes after vaccination
measure: Side effects after vaccination
timeFrame: First week after vaccination
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Infectious Diseases, Bern University Hospital
city: Bern
country: Switzerland
facility: Department of Nephrology/Hypertension, Bern University Hospital
city: Bern
country: Switzerland
facility: Department of Rheumatic Diseases, Bern University Hospital
Study officials:
affiliation: Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland
name: John M Evison, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Evison J, Farese S, Seitz M, Uehlinger DE, Furrer H, Muhlemann K. Randomized, double-blind comparative trial of subunit and virosomal influenza vaccines for immunocompromised patients. Clin Infect Dis. 2009 May 15;48(10):1402-12. doi: 10.1086/598193.