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Influenza Vaccination in Immunocompromized Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00783380
First Posted: October 31, 2008
Last Update Posted: November 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boehringer Ingelheim
Abbott
Merck Sharp & Dohme Corp.
Solvay Pharmaceuticals
Information provided by:
University Hospital Inselspital, Berne
  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
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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Reactogenicity in rheumatologic patients by disease specific scores [ Time Frame: Six weeks after vaccination ]
  • Immediate side effects at time of application of vaccination [ Time Frame: Minutes after vaccination ]
  • Side effects after vaccination [ Time Frame: First week after vaccination ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783380


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 Corp.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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)
First Submitted: October 30, 2008
First Posted: October 31, 2008
Last Update Posted: November 3, 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
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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