Influenza Vaccination in Immunocompromized Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients

Conditions
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Immunosuppression

Intervention / Treatment
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* Biological: Virosomal influenza vaccine
* Biological: Subunit influenza vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virosomal influenza vaccine<br> | Biological: Virosomal influenza vaccine<br>* Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients<br>|
| Active Comparator: Subunit influenza vaccine<br> | Biological: Subunit influenza vaccine<br>* Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40) |  | >60 Wochen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccination, Subunit, Virosomal, HIV/AIDS, Renal Dialysis, Kidney transplantation, Rheumatologic diseases, Immunogenicity, Reactogenicity