LAIV (Flumist®) Administration in CF Patients

NCT01885169 | Unknown

• 1 other identifier: 2012-4621
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

Influenza (the "flu") is one of the most common respiratory viruses associated with respiratory deteriorations in children and adolescents with cystic fibrosis. These deteriorations usually mean antibiotics, hospitalizations, and worsening of pulmonary function tests. A new flu vaccine has been recently approved for use in Canada (Flumist®). What is particular about this flu vaccine is that it is a spray in the nose, which mimics how influenza usually infects us. This particular vaccine protects children and adolescents much better than the regular injectable flu shot. This new vaccine has been given to \> 2,000 healthy children and to \>2,000 children with asthma and well tolerated. The investigators want to know if Flumist® is well tolerated in children with CF and does not cause worsening of respiratory symptoms. The investigators will conduct a study where all participants will receive Flumist® in the nose. This study is particularly important because its results will provide safety information on a vaccine that is more efficacious for a population who needs safe and easy to administer protection against the flu.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Influenza; Vaccine

Outcome Measures

Primary Outcomes (1)

• Risk of severe respiratory deterioration in the 28-day period after LAIV leading to unscheduled clinical visit or emergency department visit with or without a hospitalization, compared to the second 28-day period (D29-56).

  at-risk period (Days 1-28 post LAIV) and non at-risk period (Days 29-56)

Secondary Outcomes (1)

• Efficacy in preventing viral shedding

  Days 1, 2, 4, and 7 after LAIV

Other Outcomes (1)

• Inflammatory response in CFs in response to LAIV

  Before LAIV (day 0), and days 1, 2, 4, and 7

Study Arms (3)

Cohort A

Participants with CF; Flumist®-naïve

Biological: Flumist®

Cohort B

Siblings of Cohort A without CF; Flumist®-naïve

Biological: Flumist®

Cohort C

Participants with CF; Flumist®-experienced

Biological: Flumist®

Interventions

Flumist® BIOLOGICAL

The three cohorts will receive Flumist® and will be swabbed for inflammatory markers and viral shedding.

Also known as: Live-attenuated influenza virus, LAIV

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with CF followed in clinics in the provinces of Quebec and British Columbia

You may qualify if:

• followed in one of the participating clinics
• considered in stable condition prior to enrollment as per their physician,

You may not qualify if:

• allergic to eggs or other vaccine components
• patients for whom LAIV is contraindicated (i.e. on oral steroids for an acute asthma exacerbation or with a medically-attended wheezing episode in the 7 days prior to immunization)
• participants with clinically significant nasal polyps
• have a significant febrile illness (oral temperature ≥ 380C) at day of vaccination
• pregnant women
• immunosuppressed subjects

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Ministere de la Sante et des Services Sociaux: collaborator
• Canadian Cystic Fibrosis Foundation: collaborator
• PHAC/CIHR Influenza Research Network: collaborator

Study Sites (3)

Vaccine Evaluation Centre

Vancouver, British Columbia, V5Z 4H4, Canada

Location

The Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Centre Hospitalier de l'Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

nasal swabs

MeSH Terms

Conditions

Cystic Fibrosis; Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Caroline Quach-Thanh, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Caroline Quach-Thanh, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Infectious Diseases, Medical Microbiologist

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 24, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

CA (3)