Influenza Vaccination in Immunocompromized Patients

• ClinicalTrials.gov Identifier: NCT00783380
• Recruitment Status: Completed
• First Posted: October 31, 2008
• Last Update Posted: November 2, 2008
• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Boehringer Ingelheim; Abbott; Merck Sharp & Dohme LLC; Solvay Pharmaceuticals
• Information provided by: University Hospital Inselspital, Berne

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Immunosuppression	Biological: Virosomal influenza vaccine; Biological: Subunit influenza vaccine	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients
• Study Start Date: October 2005
• Actual Primary Completion Date: July 2006
• Actual Study Completion Date: March 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40) [ Time Frame: >60 Wochen ]

Secondary Outcome Measures :

1. Reactogenicity in rheumatologic patients by disease specific scores [ Time Frame: Six weeks after vaccination ]
2. Immediate side effects at time of application of vaccination [ Time Frame: Minutes after vaccination ]
3. Side effects after vaccination [ Time Frame: First week after vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Switzerland

Department of Infectious Diseases, Bern University Hospital

Bern, Switzerland, 3010

Department of Nephrology/Hypertension, Bern University Hospital

Bern, Switzerland, 3010

Department of Rheumatic Diseases, Bern University Hospital

Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Boehringer Ingelheim

Abbott

Merck Sharp & Dohme LLC

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. doi: 10.1034/j.1399-3062.2002.t01-4-02001.x.

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. doi: 10.1097/00002030-199404000-00008.

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. doi: 10.1258/0956462971919264.

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. doi: 10.1080/00365590310008749.

Conne P, Gauthey L, Vernet P, Althaus B, Que JU, Finkel B, Gluck R, Cryz SJ Jr. Immunogenicity of trivalent subunit versus virosome-formulated influenza vaccines in geriatric patients. Vaccine. 1997 Oct;15(15):1675-9. doi: 10.1016/s0264-410x(97)00087-x.

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. doi: 10.1016/s0264-410x(01)00060-3.

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. doi: 10.1016/s0264-410x(02)00511-x.

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

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.

• Responsible Party: Evison John, MD Oberarzt, Universitätsklinik für Infektiologie, PKT 2B, Inselspital, 3011 Bern, Switzerland
• ClinicalTrials.gov Identifier: NCT00783380
• Other Study ID Numbers: KEK No 805 (EK 151/03)
• First Posted: October 31, 2008
• Last Update Posted: November 2, 2008
• Last Verified: October 2008

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; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs