Status:
COMPLETED
Influenza Vaccine in HIV
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Ontario HIV Treatment Network
Public Health Agency of Canada (PHAC)
Conditions:
Influenza
HIV
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purposes of this research study are: 1. to see if there is a difference in the quantity of protective influenza antibodies produced by different doses of the Fluviral vaccine 2. to see if these d...
Detailed Description
Immune compromised individuals are at risk for infection with influenza and more likely to manifest more severe symptoms of influenza disease. Furthermore, they are influenza vaccine hyporesponsive in...
Eligibility Criteria
Inclusion
- Age 18 - \< 60 years
- HIV positive
- Able to provide signed, informed consent.
Exclusion
- Receipt or anticipated requirement of any blood product, vaccine, or immunoglobulin preparation within one month of study vaccine administration until completion of study.
- Immunosuppressive therapy including prednisone, immune modulators, subjects undergoing dialysis, autoimmune dysfunction (including rheumatoid arthritis, lupus erythematosus, multiple sclerosis)
- Alcohol consumption \> 4 drinks per day (1 drink is equal to a 12-ounce can of beer, or a 5-ounce glass of wine or one cocktail with 1 1/2-ounces alcohol)
- History of cancer, with the exception of cutaneous cancers including Kaposi Sarcoma, basal cell carcinoma and non-invasive HPV-related malignancy
- Known or suspected hypersensitivity to any component of the study vaccines, including chicken eggs or egg products and thimerosol
- History of immediate hypersensitivity reaction and/or reaction resulting in neurological symptoms to a previous dose of any influenza vaccine
- Presentation with or any recent history (within 24 hours) of any febrile illness (\> 38 C) or symptoms of significant local or systemic infection - such subjects will be deferred from enrollment at least until one week after the illness has resolved
- Any other condition which in the opinion of the Investigator might interfere with evaluation of the study objectives.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00764998
Start Date
October 1 2008
End Date
August 1 2009
Last Update
April 28 2017
Active Locations (13)
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1
Southern Alberta Clinic
Calgary, Alberta, Canada, T2R 0X7
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
3
BC Center for Excellence in HIV/Aids
Vancouver, British Columbia, Canada, V6Z 1Y6
4
Downtown Immunodeficiency Clinic / UBC
Vancouver, British Columbia, Canada, V6Z 2C7