Influenza Vaccination in Immunocompromized Patients

This study has been completed.
Sponsor:
Collaborators:
Boehringer Ingelheim
Abbott
MSD Chibret Switzerland
Solvay Pharmaceuticals
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00783380
First received: October 30, 2008
Last updated: October 31, 2008
Last verified: October 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reactogenicity in rheumatologic patients by disease specific scores [ Time Frame: Six weeks after vaccination ] [ Designated as safety issue: Yes ]
  • Immediate side effects at time of application of vaccination [ Time Frame: Minutes after vaccination ] [ Designated as safety issue: Yes ]
  • Side effects after vaccination [ Time Frame: First week after vaccination ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783380

Locations
Switzerland
Department of Infectious Diseases, Bern University Hospital
Bern, Switzerland, 3010
Department of Rheumatic Diseases, Bern University Hospital
Bern, Switzerland, 3010
Department of Nephrology/Hypertension, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Boehringer Ingelheim
Abbott
MSD Chibret Switzerland
Solvay Pharmaceuticals
Investigators
Principal Investigator: John M Evison, MD Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland
  More Information

Publications:

Additional 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)
Study First Received: October 30, 2008
Last Updated: October 31, 2008
Health Authority: Switzerland: Independent Local Research Ethic Commission

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

ClinicalTrials.gov processed this record on August 21, 2014