Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults

PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3 weeks (adults) or 6 weeks (children).

Study Overview

• Status: Completed
• Conditions: H1N1/2009 Influenza
• Intervention / Treatment: Biological: Arepanrix; Biological: Arepanrix

Detailed Description

During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background were more often hospitalized with severe infections than were other Canadians. Among First Nations members the hospitalization rate was 5 times higher than the national average. Common risk factors were young age (children and younger adults) and underlying health conditions. A high proportion of aboriginal adults have health conditions that predispose to adverse influenza outcomes, including diabetes, asthma, obesity and smoking-related lung diseases.

Aboriginals could benefit substantially from timely, effective vaccination against pandemic influenza and are expected to be among the first Canadians to be offered vaccine when available. The vaccine dosing recommendation will be based on limited studies in the general population, leaving open the question of whether aboriginals will respond satisfactorily to the recommended dosing. Unique social and biological factors among aboriginals could affect their responses to vaccination, reducing protection or increasing adverse effects. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest aboriginal recipients, to inform the subsequent vaccination of other aboriginal groups.

The objectives of this study are two-fold:

1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of children and adults of aboriginal background (First Nations, Metis and Inuit) with emphasis on subgroups at greatest risk of severe disease.
2. To complete this evaluation soon after the pandemic vaccines become available so as to inform the subsequent use of the vaccines in the aboriginal population.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Calgary Health Services and Alberta Children's Hospital
    • Edmonton, Alberta, Canada
      • Capital Health District, Alberta Health Services
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Child and Family Research Center
    • Vancouver, British Columbia, Canada
      • Vaccine Evaluation Center, University of British Columbia
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • University of Manitoba Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 59 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good general health
• Written informed consent provided by or for the subject
• Aboriginal ethnicity (First Nations, Metis or Inuit)
• Adults 20-59 years of age
• Children 6-35 months 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
• Compromised immune system
• Chronic illness
• Previous lab-confirmed H1N1/2009 infection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Adults: One doses of H1N12009 vaccine	Biological: Arepanrix; Adults: One dose Arepanrix vaccine given IM (0.5 mL); Biological: Arepanrix; Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
Other: 2; Children: Two doses of H1N12009 vaccine given 3 weeks apart	Biological: Arepanrix; Adults: One dose Arepanrix vaccine given IM (0.5 mL); Biological: Arepanrix; Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three 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
Comparison of baseline and post-immunization antibody titres	Day 21 (adults) and Day 42 (children)

Collaborators and Investigators

• Sponsor: David Scheifele
• Collaborators: Canadian Institutes of Health Research (CIHR); PHAC/CIHR Influenza Research Network
• Investigators: Study Director: Ethan Rubinstein, MD, University of Manitoba Health Sciences Centre; Study Director: Gerald Predy, MD, Alberta Health Services, Edmonton; Study Director: Laura Sauve, MD, University of British Columbia

Publications and helpful links

General Publications

• Rubinstein E, Predy G, Sauve L, Hammond GW, Aoki F, Sikora C, Li Y, Law B, Halperin S, Scheifele D. The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine. CMAJ. 2011 Sep 20;183(13):E1033-7. doi: 10.1503/cmaj.110196. Epub 2011 Jul 25.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: October 21, 2009
• First Submitted That Met QC Criteria: October 22, 2009
• First Posted (Estimate): October 23, 2009

Study Record Updates

• Last Update Posted (Estimate): April 10, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: vaccine; influenza; pandemic; H1N1; H1N1 influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: H09-02769