Influenza Vaccination in Immunocompromized Patients

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 4

Conditions: Immunosuppression

Treatments: Biological: Subunit influenza vaccine; Biological: Virosomal influenza vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00783380

KEK No 805 (EK 151/03)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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304 participants in 2 patient groups

Virosomal influenza vaccine

Experimental group

Treatment:

Biological: Virosomal influenza vaccine

Subunit influenza vaccine

Active Comparator group

Treatment:

Biological: Subunit influenza vaccine