Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections H1N1 Influenza |
Biological: Arepanrix |
Phase 4 |
Study Type: | Interventional |
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 ]
Enrollment: | 150 |
Study Start Date: | February 2010 |
Study Completion Date: | August 2010 |
Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Group A: One dose of H1N1 vaccine
|
Biological: Arepanrix
Group A receives one dose of Arepanrix
|
2
Group B: Two doses of H1N1 vaccine given 3-4 weeks apart
|
Biological: Arepanrix
Group B receives 2 doses of Arepanrix 3 weeks apart
|
Detailed Description:
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.
![](https://webarchive.library.unt.edu/web/20130315212418im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 20 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Laboratory-confirmed HIV
- Written informed consent
- Adults 20-59 years of age
Exclusion Criteria:
- Allergies to eggs, thimerosal or gentamicin sulphate
- Life-threatening reaction to previous Flu vaccine
- Bleeding disorder
- Pregnancy
- Receipt of blood or blood products in past 3 months
- Chronic illness
- Previous lab-confirmed H1N12009 infection
- Receipt of any non-study H1N12009 or Seasonal Influenza vaccine for 2009/10
![](https://webarchive.library.unt.edu/web/20130315212418im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Canada, Nova Scotia | |
Dalhousie University | |
Halifax, Nova Scotia, Canada | |
Canada, Ontario | |
University of Ottawa / Ottawa Hospital Research Institute | |
Ottawa, Ontario, Canada | |
University of Toronto | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
McGill University | |
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 |
![](https://webarchive.library.unt.edu/web/20130315212418im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided by University of British Columbia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT01002040 History of Changes |
Other Study ID Numbers: | H09-02820 |
Study First Received: | October 23, 2009 |
Last Updated: | March 9, 2012 |
Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
HIV vaccine, H1N1 influenza H1N1 Influenza vaccine |
Arepanrix Pandemic H1N1 2009 Influenza HIV preventive vaccine |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Influenza, Human Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on March 14, 2013