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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; H1N1 Influenza
• Intervention / Treatment: Biological: Arepanrix; Biological: Arepanrix

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
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Dalhousie University
  • Ontario
    • Ottawa, Ontario, Canada
      • University of Ottawa / Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada
      • University of Toronto
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: One Dose Influenza vaccine; Arepanrix H1N1 Influenza vaccine (one dose)	Biological: Arepanrix; Group A receives one dose of Arepanrix; Biological: Arepanrix; Group B receives 2 doses of Arepanrix 3 weeks apart
Active Comparator: Two Doses Influenza vaccine; Arepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart)	Biological: Arepanrix; Group A receives one dose of Arepanrix; Biological: Arepanrix; Group B receives 2 doses of Arepanrix 3 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events (AEs) for days 0-6 after each vaccination	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	Day 7 and Day 21 post vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity: Comparison of baseline and post-immunization antibody titres	Day 21 post vaccination

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: GlaxoSmithKline; Canadian Institutes of Health Research (CIHR)
• Investigators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: HIV; influenza; vaccine,; Pandemic; HIV preventive vaccine; H1N1; Arepanrix; H1N1 Influenza vaccine; H1N1 2009 Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Infections; Influenza, Human
• Other Study ID Numbers: H09-02820