Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in HIV-infected adults. The study will enroll 150 adults (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 days.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection|
- Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
- Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
- Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: One Dose Influenza vaccine
Arepanrix H1N1 Influenza vaccine (one dose)
Group A receives one dose of Arepanrix
Active Comparator: Two Doses Influenza vaccine
Arepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart)
Group B receives 2 doses of Arepanrix 3 weeks apart
During the first wave of the H1N12009 pandemic in Canada, adults with immune deficiency were more likely to die with severe infections than were other Canadians. Of 76 deaths attributed to date to this new virus, 37% occurred in persons with immune system compromise. Adults with human immunodeficiency virus (HIV) infection constitute a significant proportion of the at-risk population with over 56,000 affected individuals. Most such individuals retain some capacity to respond to influenza vaccination. The dosing regimen for the pandemic vaccine will be based on limited studies in the general population, leaving open the question of whether HIV-infected persons can respond satisfactorily to the recommended dosing. Availability of an adjuvanted formulation of the pandemic vaccine may improve responsiveness but two doses may be required for the best possible response. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest HIV-infected persons to receive it, to inform the subsequent vaccination of others.
The objectives of this study are three-fold:
- To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults with HIV infection.
- To compare immune responses of subjects randomized to receive either one or two doses of adjuvanted vaccine to identify the optimal regimen.
- To complete this evaluation soon after the pandemic vaccine becomes available so as to inform the subsequent use of the vaccine in HIV-infected persons.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002040
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada|
|University of Ottawa / Ottawa Hospital Research Institute|
|Ottawa, Ontario, Canada|
|University of Toronto|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Principal Investigator:||David Scheifele, MD||University of British Columbia|
|Study Director:||Curtis Cooper, MD||University of Ottawa / Ottawa Hospital Research Institute,|
|Study Director:||Marina Klein, MD||McGill University|
|Study Director:||Brian Ward, MD||McGill University|
|Study Director:||Sharon Walmsley, MD||University of Toronto|
|Study Director:||Allison McGeer, MD||University of Toronto|
|Study Director:||David Hasse, MD||Dalhousie University|
|Study Director:||Shelly McNeil, MD||Dalhousie University|