Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study
File(s)
Published version
Accepted version
Author(s)
Turner, PJ
Southern, J
Andrews, N
Miller, E
Erlewyn-Lajeunesse, M
Type
Journal Article
Abstract
Study question How safe is live attenuated influenza vaccine (LAIV), which contains egg protein, in young people with egg allergy?
Methods In this open label, phase IV intervention study, 779 young people (2-18 years) with egg allergy were recruited from 30 UK allergy centres and immunised with LAIV. The cohort included 270 (34.7%) young people with previous anaphylaxis to egg, of whom 157 (20.1%) had experienced respiratory and/or cardiovascular symptoms. 445 (57.1%) had doctor diagnosed asthma or recurrent wheeze. Participants were observed for at least 30 minutes after vaccination and followed-up by telephone 72 hours later. Participants with a history of recurrent wheeze or asthma underwent further follow-up four weeks later. The main outcome measure was incidence of an adverse event within two hours of vaccination in young people with egg allergy.
Study answer and limitations No systemic allergic reactions occurred (upper 95% confidence interval for population 0.47% and in participants with anaphylaxis to egg 1.36%). Nine participants (1.2%, 95% CI 0.5% to 2.2%) experienced mild symptoms, potentially consistent with a local, IgE mediated allergic reaction. Delayed events potentially related to the vaccine were reported in 221 participants. 62 participants (8.1%, 95% CI for population 6.3% to 10.3%) experienced lower respiratory tract symptoms within 72 hours, including 29 with parent reported wheeze. No participants were admitted to hospital. No increase in lower respiratory tract symptoms occurred in the four weeks after vaccination (assessed with asthma control test). The study cohort may represent young people with more severe allergy requiring specialist input, since they were recruited from secondary and tertiary allergy centres.
What this study adds LAIV is associated with a low risk of systemic allergic reactions in young people with egg allergy. The vaccine seems to be well tolerated in those with well controlled asthma or recurrent wheeze.
Methods In this open label, phase IV intervention study, 779 young people (2-18 years) with egg allergy were recruited from 30 UK allergy centres and immunised with LAIV. The cohort included 270 (34.7%) young people with previous anaphylaxis to egg, of whom 157 (20.1%) had experienced respiratory and/or cardiovascular symptoms. 445 (57.1%) had doctor diagnosed asthma or recurrent wheeze. Participants were observed for at least 30 minutes after vaccination and followed-up by telephone 72 hours later. Participants with a history of recurrent wheeze or asthma underwent further follow-up four weeks later. The main outcome measure was incidence of an adverse event within two hours of vaccination in young people with egg allergy.
Study answer and limitations No systemic allergic reactions occurred (upper 95% confidence interval for population 0.47% and in participants with anaphylaxis to egg 1.36%). Nine participants (1.2%, 95% CI 0.5% to 2.2%) experienced mild symptoms, potentially consistent with a local, IgE mediated allergic reaction. Delayed events potentially related to the vaccine were reported in 221 participants. 62 participants (8.1%, 95% CI for population 6.3% to 10.3%) experienced lower respiratory tract symptoms within 72 hours, including 29 with parent reported wheeze. No participants were admitted to hospital. No increase in lower respiratory tract symptoms occurred in the four weeks after vaccination (assessed with asthma control test). The study cohort may represent young people with more severe allergy requiring specialist input, since they were recruited from secondary and tertiary allergy centres.
What this study adds LAIV is associated with a low risk of systemic allergic reactions in young people with egg allergy. The vaccine seems to be well tolerated in those with well controlled asthma or recurrent wheeze.
Date Issued
2015-12-08
Date Acceptance
2015-11-05
Citation
British Medical Journal, 2015, 351, pp.1-7
ISSN
1468-5833
Publisher
BMJ Publishing Group
Start Page
1
End Page
7
Journal / Book Title
British Medical Journal
Volume
351
Copyright Statement
© BMJ Publishing Group Ltd 2015. This is an Open Access article distributed in accordance with the terms
of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See:http://creativecommons.org/licenses/by/4.0/.
of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See:http://creativecommons.org/licenses/by/4.0/.
License URL
Sponsor
Medical Research Council (MRC)
Imperial College Healthcare NHS Trust - CLRN Funding
Identifier
https://www.bmj.com/content/351/bmj.h6291
Grant Number
MR/K010468/1
WMNP_P49187
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
NONRECOMMENDED CHILDREN YOUNGER
POSTMARKETING EVALUATION
FOOD ANAPHYLAXIS
INTRANASAL
EFFICACY
GUIDELINES
FREQUENCY
COMMITTEE
ASTHMA
LAIV
Adolescent
Child
Child, Preschool
Dose-Response Relationship, Drug
Egg Hypersensitivity
Female
Follow-Up Studies
Humans
Influenza A virus
Influenza Vaccines
Influenza, Human
Male
Prospective Studies
Treatment Outcome
United Kingdom
Vaccination
Vaccines, Attenuated
SNIFFLE-2 Study Investigators
Humans
Influenza A virus
Egg Hypersensitivity
Vaccines, Attenuated
Influenza Vaccines
Treatment Outcome
Vaccination
Follow-Up Studies
Prospective Studies
Dose-Response Relationship, Drug
Adolescent
Child
Child, Preschool
Female
Male
Influenza, Human
United Kingdom
General & Internal Medicine
1103 Clinical Sciences
1117 Public Health and Health Services
Publication Status
Published
Article Number
h6291
Date Publish Online
2015-12-08