Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma.
Adolescent
Asthma
/ immunology
Child
Child, Preschool
Disease Progression
Female
Follow-Up Studies
Humans
Influenza Vaccines
/ immunology
Influenza, Human
/ immunology
Male
Orthomyxoviridae
/ physiology
Prospective Studies
Respiratory Function Tests
Respiratory Sounds
United Kingdom
Vaccination
Vaccines, Attenuated
/ immunology
Asthma
children
immunization
influenza
live attenuated influenza vaccine
Journal
The Journal of allergy and clinical immunology
ISSN: 1097-6825
Titre abrégé: J Allergy Clin Immunol
Pays: United States
ID NLM: 1275002
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
23
10
2019
revised:
07
12
2019
accepted:
12
12
2019
pubmed:
22
12
2019
medline:
26
1
2021
entrez:
22
12
2019
Statut:
ppublish
Résumé
Live attenuated influenza vaccine (LAIV) is recommended for annual influenza vaccination in children from age 2 years. However, some guidelines recommend against its use in children with asthma or recurrent wheeze due to concerns over its potential to induce wheezing. We sought to assess the safety of LAIV in children with moderate to severe asthma, and in preschool children with recurrent wheeze. Prospective, multicenter, open-label, phase IV intervention study in 14 specialist UK clinics. LAIV was administered under medical supervision, with follow-up of asthma symptoms 72 hours and 4 weeks late, using validated questionnaires. A total of 478 young people (median, 9.3; range, 2-18 years) with physician-diagnosed asthma or recurrent wheeze were recruited, including 208 (44%) prescribed high-dose inhaled corticosteroids and 122 (31%) with severe asthma. There was no significant change in asthma symptoms in the 4 weeks after administration (median change, 0; P = .26, McNemar test), with no impact of level of baseline asthma control/symptoms in predicting either a worsening of asthma or exacerbation after LAIV using a regression model. A total of 47 subjects (14.7%; 95% CI, 11%-19.1%) reported a severe asthma exacerbation in the 4 weeks after immunization, requiring a short course of systemic corticosteroids; in 4 cases, this occurred within 72 hours of vaccination. No association with asthma severity, baseline lung function, or asthma control was identified. LAIV appears to be well tolerated in the vast majority of children with asthma or recurrent wheeze, including those whose asthma is categorized as severe or poorly controlled.
Sections du résumé
BACKGROUND
Live attenuated influenza vaccine (LAIV) is recommended for annual influenza vaccination in children from age 2 years. However, some guidelines recommend against its use in children with asthma or recurrent wheeze due to concerns over its potential to induce wheezing.
OBJECTIVE
We sought to assess the safety of LAIV in children with moderate to severe asthma, and in preschool children with recurrent wheeze.
METHODS
Prospective, multicenter, open-label, phase IV intervention study in 14 specialist UK clinics. LAIV was administered under medical supervision, with follow-up of asthma symptoms 72 hours and 4 weeks late, using validated questionnaires.
RESULTS
A total of 478 young people (median, 9.3; range, 2-18 years) with physician-diagnosed asthma or recurrent wheeze were recruited, including 208 (44%) prescribed high-dose inhaled corticosteroids and 122 (31%) with severe asthma. There was no significant change in asthma symptoms in the 4 weeks after administration (median change, 0; P = .26, McNemar test), with no impact of level of baseline asthma control/symptoms in predicting either a worsening of asthma or exacerbation after LAIV using a regression model. A total of 47 subjects (14.7%; 95% CI, 11%-19.1%) reported a severe asthma exacerbation in the 4 weeks after immunization, requiring a short course of systemic corticosteroids; in 4 cases, this occurred within 72 hours of vaccination. No association with asthma severity, baseline lung function, or asthma control was identified.
CONCLUSIONS
LAIV appears to be well tolerated in the vast majority of children with asthma or recurrent wheeze, including those whose asthma is categorized as severe or poorly controlled.
Identifiants
pubmed: 31863808
pii: S0091-6749(19)31712-9
doi: 10.1016/j.jaci.2019.12.010
pmc: PMC7156909
pii:
doi:
Substances chimiques
Influenza Vaccines
0
Vaccines, Attenuated
0
Types de publication
Clinical Trial, Phase IV
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1157-1164.e6Subventions
Organisme : Medical Research Council
ID : MR/K010468/1
Pays : United Kingdom
Organisme : Department of Health
Pays : United Kingdom
Investigateurs
Alexandra Adams
(A)
Christine Doyle
(C)
Michel Erlewyn-Lajeunesse
(M)
Katy Fidler
(K)
Louise Fleming
(L)
Atul Gupta
(A)
Stephen M Hughes
(SM)
Andrew Ives
(A)
Nicola Jay
(N)
Sonal Kansra
(S)
Louise Michaelis
(L)
Samantha Moss
(S)
Clare Murray
(C)
Prasad Nagakumar
(P)
Graham Roberts
(G)
Sejal Saglani
(S)
Paul Seddon
(P)
Ian Sinha
(I)
Gary Stiefel
(G)
Huw M Thomas
(HM)
Paul J Turner
(PJ)
Informations de copyright
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.
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