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Influenza Vaccination in Immunocompromized Patients

Primary Purpose

Immunosuppression

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Virosomal influenza vaccine
Subunit influenza vaccine
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunosuppression focused on measuring Influenza vaccination, Subunit, Virosomal, HIV/AIDS, Renal Dialysis, Kidney transplantation, Rheumatologic diseases, Immunogenicity, Reactogenicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virosomal influenza vaccine

Subunit influenza vaccine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reactogenicity in rheumatologic patients by disease specific scores
Immediate side effects at time of application of vaccination
Side effects after vaccination

Full Information

First Posted
October 30, 2008
Last Updated
October 31, 2008
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Boehringer Ingelheim, Abbott, Merck Sharp & Dohme LLC, Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00783380
Brief Title
Influenza Vaccination in Immunocompromized Patients
Official Title
Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Boehringer Ingelheim, Abbott, Merck Sharp & Dohme LLC, Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunosuppression
Keywords
Influenza vaccination, Subunit, Virosomal, HIV/AIDS, Renal Dialysis, Kidney transplantation, Rheumatologic diseases, Immunogenicity, Reactogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virosomal influenza vaccine
Arm Type
Experimental
Arm Title
Subunit influenza vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Virosomal influenza vaccine
Intervention Description
Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Intervention Type
Biological
Intervention Name(s)
Subunit influenza vaccine
Intervention Description
Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
Primary Outcome Measure Information:
Title
Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)
Time Frame
>60 Wochen
Secondary Outcome Measure Information:
Title
Reactogenicity in rheumatologic patients by disease specific scores
Time Frame
Six weeks after vaccination
Title
Immediate side effects at time of application of vaccination
Time Frame
Minutes after vaccination
Title
Side effects after vaccination
Time Frame
First week after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Evison, MD
Organizational Affiliation
Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Department of Nephrology/Hypertension, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Department of Rheumatic Diseases, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
12535259
Citation
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Results Reference
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PubMed Identifier
11334444
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.
Results Reference
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PubMed Identifier
7912086
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. doi: 10.1097/00002030-199404000-00008.
Results Reference
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PubMed Identifier
9433953
Citation
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PubMed Identifier
7966058
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.
Results Reference
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PubMed Identifier
12465151
Citation
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Results Reference
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PubMed Identifier
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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. doi: 10.1080/00365590310008749.
Results Reference
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PubMed Identifier
9364699
Citation
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Citation
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Citation
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Citation
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Results Reference
derived

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Influenza Vaccination in Immunocompromized Patients

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