Influenza Vaccination in Immunocompromized Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Immunosuppression	Biological: Virosomal influenza vaccine Biological: Subunit influenza vaccine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40) [ Time Frame: >60 Wochen ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	304
Study Start Date:	October 2005
Study Completion Date:	March 2008
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783380

Locations

Switzerland
Department of Infectious Diseases, Bern University Hospital
Bern, Switzerland, 3010
Department of Rheumatic Diseases, Bern University Hospital
Bern, Switzerland, 3010
Department of Nephrology/Hypertension, Bern University Hospital
Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Boehringer Ingelheim Pharmaceuticals

Abbott

MSD Chibret Switzerland

Solvay Pharmaceuticals

Investigators

Principal Investigator:

John M Evison, MD

Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland

More Information

Publications:

Vilchez RA, Fung J, Kusne S. The pathogenesis and management of influenza virus infection in organ transplant recipients. Transpl Infect Dis. 2002 Dec;4(4):177-82. Review.

Bridges CB, Fukuda K, Cox NJ, Singleton JA; Advisory Committee on Immunization Practices. Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2001 Apr 20;50(RR-4):1-44.

Kroon FP, van Dissel JT, de Jong JC, van Furth R. Antibody response to influenza, tetanus and pneumococcal vaccines in HIV-seropositive individuals in relation to the number of CD4+ lymphocytes. AIDS. 1994 Apr;8(4):469-76.

Dorrell L, Hassan I, Marshall S, Chakraverty P, Ong E. Clinical and serological responses to an inactivated influenza vaccine in adults with HIV infection, diabetes, obstructive airways disease, elderly adults and healthy volunteers. Int J STD AIDS. 1997 Dec;8(12):776-9.

Chalmers A, Scheifele D, Patterson C, Williams D, Weber J, Shuckett R, Teufel A. Immunization of patients with rheumatoid arthritis against influenza: a study of vaccine safety and immunogenicity. J Rheumatol. 1994 Jul;21(7):1203-6.

Abu-Shakra M, Press J, Varsano N, Levy V, Mendelson E, Sukenik S, Buskila D. Specific antibody response after influenza immunization in systemic lupus erythematosus. J Rheumatol. 2002 Dec;29(12):2555-7.

Cavdar C, Sayan M, Sifil A, Artuk C, Yilmaz N, Bahar H, Camsari T. The comparison of antibody response to influenza vaccination in continuous ambulatory peritoneal dialysis, hemodialysis and renal transplantation patients. Scand J Urol Nephrol. 2003;37(1):71-6.

Conne P, Gauthey L, Vernet P, Althaus B, Que JU, Finkel B, Glück R, Cryz SJ Jr. Immunogenicity of trivalent subunit versus virosome-formulated influenza vaccines in geriatric patients. Vaccine. 1997 Oct;15(15):1675-9.

Baldo V, Menegon T, Bonello C, Floreani A, Trivello R; Collaborative Group. Comparison of three different influenza vaccines in institutionalised elderly. Vaccine. 2001 May 14;19(25-26):3472-5.

Zanetti AR, Amendola A, Besana S, Boschini A, Tanzi E. Safety and immunogenicity of influenza vaccination in individuals infected with HIV. Vaccine. 2002 Dec 20;20 Suppl 5:B29-32. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Evison J, Farese S, Seitz M, Uehlinger DE, Furrer H, Mühlemann 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.

Responsible Party:	Evison John, MD Oberarzt, Universitätsklinik für Infektiologie, PKT 2B, Inselspital, 3011 Bern, Switzerland
ClinicalTrials.gov Identifier:	NCT00783380 History of Changes
Other Study ID Numbers:	KEK No 805 (EK 151/03)
Study First Received:	October 30, 2008
Last Updated:	October 31, 2008
Health Authority:	Switzerland: Independent Local Research Ethic Commission

Keywords provided by University Hospital Inselspital, Berne:

Influenza vaccination
Subunit
Virosomal
HIV/AIDS
Renal Dialysis

Kidney transplantation
Rheumatologic diseases
Immunogenicity
Reactogenicity

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 10, 2013