Clinical trial NCT02111512: Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
Official title: Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Egg Hypersensitivity
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: Public Health England
First posted: 2014-04-11
Enrollment: 779
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Egg allergy is common in early childhood, affecting at least one in 50 preschool children. Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs. There is robust data to support the safety of influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy.

A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. This new vaccine has been available in the United States for several years and is highly effective and against influenza infection, with an excellent safety profile in children without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed.

The objective of this multicentre study is to further assess the safety of intranasal LAIV in egg-allergic children, in order to demonstrate that these children can safely be given the new LAIV within a primary care health environment.


Eligibility criteria: Inclusion Criteria:

* Aged 2 - 17 years old
* Physician-diagnosis of egg allergy

Exclusion Criteria:

1. Clinical resolution of egg allergy
2. Contraindications to LAIV (notwithstanding allergy to egg protein):

   * Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
   * Previous systemic allergic reaction to LAIV
   * Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
   * Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids. NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
   * Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
3. Contraindication to vaccination on that occasion, due to child being acutely unwell:

   * Febrile ≥38.0oC in last 72 hours
   * Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
   * Recent admission to hospital in last 2 weeks for acute asthma
   * Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Primary outcomes:
measure: Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
timeFrame: Within 2 hours of vaccine administration
Secondary outcomes:
measure: Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
timeFrame: 72 hours after vaccine administration
measure: Asthma control test
timeFrame: 4 weeks post LAIV
Other outcomes:
measure: Incidence of immediate allergic reaction to LAIV in the subgroups described below.
timeFrame: Within 2 hours of vaccine administration
Locations:
city: Belfast
country: United Kingdom
facility: Ulster Hospital
state: Northern Ireland
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath NHS Trust
city: Birmingham
country: United Kingdom
facility: Sandwell General Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
city: Hereford
country: United Kingdom
facility: Wye Valley NHS Trust
city: Huntingdon
country: United Kingdom
facility: Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
city: Leeds
country: United Kingdom
facility: Leeds Children's Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Evelina Children's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust (St. Mary's Hospital)
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: London St George's Hospital
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Children's
city: Newcastle
country: United Kingdom
facility: Newcastle Freeman Hospital
city: Oxford
country: United Kingdom
facility: Oxford
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital NHS Foundation Trust
city: Shrewsbury
country: United Kingdom
facility: Shrewsbury and Telford Hospital NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton NHS Foundation Trust
city: Warrington
country: United Kingdom
facility: Warrington & Halton Hospitals NHS Foundation Trust
city: Winchester
country: United Kingdom
facility: Hampshire Hospital NHS Foundation Trust
Study officials:
affiliation: University Hospitals Southampton NHS Foundation Trust
name: Mich Erlewyn-Lajeunesse, DM FRCPCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Paul J Turner, FRACP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE-2 Study Investigators. Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study. BMJ. 2015 Dec 8;351:h6291. doi: 10.1136/bmj.h6291.