Influenza Vaccination in Immunocompromized Patients

• Reactogenicity in rheumatologic patients by disease specific scores [ Time Frame: Six weeks after vaccination ] [ Designated as safety issue: Yes ]
• Immediate side effects at time of application of vaccination [ Time Frame: Minutes after vaccination ] [ Designated as safety issue: Yes ]
• Side effects after vaccination [ Time Frame: First week after vaccination ] [ Designated as safety issue: No ]

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.

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.

• Biological: Virosomal influenza vaccine
  Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
• Biological: Subunit influenza vaccine
  Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients

• Experimental: Virosomal influenza vaccine
  Intervention: Biological: Virosomal influenza vaccine
• Active Comparator: Subunit influenza vaccine
  Intervention: Biological: Subunit influenza vaccine

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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

• Boehringer Ingelheim Pharmaceuticals
• Abbott
• MSD Chibret Switzerland
• Solvay Pharmaceuticals