HIV Clinical Trial
Official title:
A Controlled Trial to Assess the Immunogenicity and Efficacy of Three Vaccine Dosing Strategies in HIV Infected Adults
Verified date | April 2017 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 different vaccine dosing schedules reduce flu-like illness and/or
reduce laboratory documented influenza in HIV Infected adults.
Status | Completed |
Enrollment | 285 |
Est. completion date | August 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Age 18 - < 60 years - HIV positive - Able to provide signed, informed consent. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Southern Alberta Clinic | Calgary | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | QEII HSC, Victoria General Hospital Site | Halifax | Nova Scotia |
Canada | McMaster University Medical Center | Hamilton | Ontario |
Canada | Infectious Disease Care Program | London | Ontario |
Canada | Immunodeficiency Service, Montreal Chest Institute | Montreal | Quebec |
Canada | The Ottawa Hospital, General Campus | Ottawa | Ontario |
Canada | Sunnybrook Health Science Center | Toronto | Ontario |
Canada | University Health Network | Toronto | Ontario |
Canada | University of Ottawa Health Services | Toronto | Ontario |
Canada | BC Center for Excellence in HIV/Aids | Vancouver | British Columbia |
Canada | Downtown Immunodeficiency Clinic / UBC | Vancouver | British Columbia |
Canada | HIV Care Program - Windsor Regional Hospital | Windsor | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | CIHR Canadian HIV Trials Network, Ontario HIV Treatment Network, Public Health Agency of Canada (PHAC) |
Canada,
Cooper C, Thorne A, Klein M, Conway B, Boivin G, Haase D, Shafran S, Zubyk W, Singer J, Halperin S, Walmsley S; CIHR Canadian HIV Trials Network Influenza Vaccine Research Group.. Immunogenicity is not improved by increased antigen dose or booster dosing — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity measured by haemagglutination inhibition (HI) | baseline, week 4, week 8 and week 20. | ||
Secondary | Frequencies of laboratory confirmed influenza and Frequencies clinical/respiratory illness | event driven |
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