Clinical trial NCT01001026: Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: H1N1/2009 Influenza
Keywords: vaccine
H1N1
influenza
H1N1 influenza vaccine
pandemic
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: PHAC/CIHR Influenza Research Network
First posted: 2009-10-23
Enrollment: 156
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of adverse events (AEs) for days 0-6 after each vaccination
timeFrame: Day 7 and Day 21 post vaccination
measure: Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination
timeFrame: Day 7 and Day 21 post vaccination
Secondary outcomes:
measure: Comparison of baseline and post-immunization antibody titres
timeFrame: Day 21 (adults) and Day 42 (children)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Health Services and Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Capital Health District, Alberta Health Services
state: Alberta
city: Vancouver
country: Canada
facility: Child and Family Research Center
state: British Columbia
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center, University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of British Columbia
name: David Scheifele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba Health Sciences Centre
name: Ethan Rubinstein, MD
role: STUDY_DIRECTOR
affiliation: Alberta Health Services, Edmonton
name: Gerald Predy, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Laura Sauve, MD
role: STUDY_DIRECTOR
References:
citation: 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.