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. Identifier: NCT01002040
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : April 15, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections H1N1 Influenza Biological: Arepanrix Phase 4

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:

  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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot HIV/AIDS

Arm Intervention/treatment
Active Comparator: One Dose Influenza vaccine
Arepanrix H1N1 Influenza vaccine (one dose)
Biological: Arepanrix
Group A receives one dose of Arepanrix

Active Comparator: Two Doses Influenza vaccine
Arepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart)
Biological: Arepanrix
Group B receives 2 doses of Arepanrix 3 weeks apart

Primary Outcome Measures :
  1. Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ]
  2. 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 ]

Secondary Outcome Measures :
  1. Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01002040

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
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of British Columbia Identifier: NCT01002040     History of Changes
Other Study ID Numbers: H09-02820
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by University of British Columbia:
H1N1 Influenza vaccine
H1N1 2009 Influenza
HIV preventive vaccine

Additional relevant MeSH terms:
Influenza, Human
HIV Infections
Acquired Immunodeficiency Syndrome
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Immunologic Factors
Physiological Effects of Drugs