Influenza Vaccination in Immunocompromized Patients
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![](https://webarchive.library.unt.edu/web/20130312001125im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
- Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40) [ Time Frame: >60 Wochen ] [ Designated as safety issue: No ]
- 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.
![](https://webarchive.library.unt.edu/web/20130312001125im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130312001125im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
Principal Investigator: | John M Evison, MD | Department of Infectious Diseases, University Hospital Bern, 3010-Bern, Switzerland |
![](https://webarchive.library.unt.edu/web/20130312001125im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 March 10, 2013