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Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01002040
First received: October 23, 2009
Last updated: March 9, 2012
Last verified: March 2012

October 23, 2009
March 9, 2012
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 ] [ 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 ]
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 ] [ Designated as safety issue: No ]
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
  • 1
    Group A: One dose of H1N1 vaccine
    Intervention: Biological: Arepanrix
  • 2
    Group B: Two doses of H1N1 vaccine given 3-4 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.
 
Completed
150
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
Both
20 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01002040
H09-02820
No
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
March 2012

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