Trial record 16 of 47 for:    " September 23, 2009":" October 23, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:

  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.
  Eligibility

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002040

Locations
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)
GlaxoSmithKline
Investigators
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
  More Information

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 April 16, 2014