Influenza Vaccination in Immunocompromized Patients

Immunosuppression Clinical Trial

Official title:

Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783380
• Other study ID #: KEK No 805 (EK 151/03)
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2008
• Last updated: October 31, 2008
• Start date: October 2005
• Est. completion date: March 2008

Study information

• Verified date: October 2008
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Independent Local Research Ethic Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: March 2008
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immunosuppression

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Infectious Diseases, Bern University Hospital	Bern
Switzerland	Department of Nephrology/Hypertension, Bern University Hospital	Bern
Switzerland	Department of Rheumatic Diseases, Bern University Hospital	Bern

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Abbott, Boehringer Ingelheim, Merck Sharp & Dohme Corp., Solvay Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)		>60 Wochen	No
Secondary	Reactogenicity in rheumatologic patients by disease specific scores		Six weeks after vaccination	Yes
Secondary	Immediate side effects at time of application of vaccination		Minutes after vaccination	Yes
Secondary	Side effects after vaccination		First week after vaccination	No