Egg Hypersensitivity
Conditions
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.
Interventions
Sponsors
Imperial College London
Public Health England
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children | Within 2 hours of vaccine administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children | 72 hours after vaccine administration | — |
| Asthma control test | 4 weeks post LAIV | To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of immediate allergic reaction to LAIV in the subgroups described below. | Within 2 hours of vaccine administration | 1. By age group 2-5, 6-11, 12-17 years 2. Children with a clinician-assessed history of reaction to egg in the previous 12 months 3. Children with evidence of \>95% likelihood of egg allergy (as per published criteria) within the past 3 months 4. Children with evidence of \>95% likelihood of egg allergy (as per published criteria) within the past 12 months 5. children with a previous history of anaphylaxis to egg protein 6. children who have reacted previously to airborne traces of egg 7. children who have egg allergy but are tolerant of baked egg 8. Children who have previously received influenza vaccine 9. Presence of physician-diagnosed asthma / recurrent wheeze |
Countries
United Kingdom
Outcome results
None listed