Influenza Vaccination in Immunocompromized Patients

NCT00783380 | Completed Phase 4

• 1 other identifier: KEK No 805 (EK 151/03)
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 3

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.

Conditions

Immunosuppression

Keywords

Influenza vaccination; Subunit; Virosomal; HIV/AIDS; Renal Dialysis; Kidney transplantation; Rheumatologic diseases; Immunogenicity; Reactogenicity

Outcome Measures

Primary Outcomes (1)

• Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)

  >60 Wochen

Secondary Outcomes (3)

• Reactogenicity in rheumatologic patients by disease specific scores

  Six weeks after vaccination

• Immediate side effects at time of application of vaccination

  Minutes after vaccination

• Side effects after vaccination

  First week after vaccination

Study Arms (2)

Virosomal influenza vaccine

EXPERIMENTAL

Biological: Virosomal influenza vaccine

Subunit influenza vaccine

ACTIVE COMPARATOR

Biological: Subunit influenza vaccine

Interventions

Virosomal influenza vaccine BIOLOGICAL

Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients

Virosomal influenza vaccine

Subunit influenza vaccine BIOLOGICAL

Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients

Subunit influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to egg proteins
• Former adverse reactions to prior vaccination

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Boehringer Ingelheim: collaborator
• Abbott: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Solvay Pharmaceuticals: collaborator

Study Sites (3)

Department of Infectious Diseases, Bern University Hospital

Bern, 3010, Switzerland

Location

Department of Nephrology/Hypertension, Bern University Hospital

Bern, 3010, Switzerland

Location

Department of Rheumatic Diseases, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (11)

• 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.

  PMID: 12535259 BACKGROUND

• 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.

  PMID: 11334444 BACKGROUND

• 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.

  PMID: 7912086 BACKGROUND

• 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.

  PMID: 9433953 BACKGROUND

• 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.

  PMID: 7966058 BACKGROUND

• 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.

  PMID: 12465151 BACKGROUND

• 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.

  PMID: 12745749 BACKGROUND

• 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.

  PMID: 9364699 BACKGROUND

• 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.

  PMID: 11348713 BACKGROUND

• 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.

  PMID: 12477415 BACKGROUND

• 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.

  PMID: 19361304 DERIVED

MeSH Terms

Conditions

Influenza, Human; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• John M Evison, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: October 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: March 1, 2008
• Last Updated: November 3, 2008

Record last verified: 2008-10

Locations

CH (3)