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Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01002040
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):

October 23, 2009
October 27, 2009
April 15, 2015
February 2010
July 2010   (Final data collection date for primary outcome measure)
  • Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01002040 on ClinicalTrials.gov Archive Site
Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ]
Same as current
Not Provided
Not Provided
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection
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.

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:

  1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults with HIV infection.
  2. To compare immune responses of subjects randomized to receive either one or two doses of adjuvanted vaccine to identify the optimal regimen.
  3. 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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • HIV Infections
  • H1N1 Influenza
  • Biological: Arepanrix
    Group A receives one dose of Arepanrix
  • Biological: Arepanrix
    Group B receives 2 doses of Arepanrix 3 weeks apart
  • Active Comparator: One Dose Influenza vaccine
    Arepanrix H1N1 Influenza vaccine (one dose)
    Intervention: Biological: Arepanrix
  • Active Comparator: Two Doses Influenza vaccine
    Arepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart)
    Intervention: Biological: Arepanrix
Cooper C, Klein M, Walmsley S, Haase D, MacKinnon-Cameron D, Marty K, Li Y, Smith B, Halperin S, Law B, Scheifele D; Phac Cihr Influenza Research Network. High-level immunogenicity is achieved vaccine with adjuvanted pandemic H1N1(2009) and improved with booster dosing in a randomized trial of HIV-infected adults. HIV Clin Trials. 2012 Jan-Feb;13(1):23-32. doi: 10.1310/hct1301-023.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 59 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
University of British Columbia
University of British Columbia
  • Canadian Institutes of Health Research (CIHR)
  • GlaxoSmithKline
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
University of British Columbia
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP