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Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma

Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma
Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma

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.

Asthma, children, immunization, influenza, live attenuated influenza vaccine
0091-6749
1157-1164.e6
Turner, Paul J.
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Fleming, Louise
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Saglani, Sejal
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Southern, Jo
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Andrews, Nick J.
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Miller, Elizabeth
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Adams, Alexandra
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Doyle, Christine
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Erlewyn-Lajeunesse, Michel
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Fidler, Katy
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Gupta, Atul
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Hughes, Stephen M.
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Ives, Andrew
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Jay, Nicola
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Kansra, Sonal
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Michaelis, Louise
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Moss, Samantha
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Murray, Clare
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Roberts, Graham
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SNIFFLE-4 Study Investigators
Turner, Paul J.
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Fleming, Louise
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Saglani, Sejal
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Southern, Jo
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Andrews, Nick J.
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Miller, Elizabeth
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Adams, Alexandra
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Doyle, Christine
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Erlewyn-Lajeunesse, Michel
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Fidler, Katy
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Gupta, Atul
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Hughes, Stephen M.
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Ives, Andrew
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Jay, Nicola
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Kansra, Sonal
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Michaelis, Louise
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Moss, Samantha
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Murray, Clare
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Nagakumar, Prasad
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Roberts, Graham
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Seddon, Paul
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Sinha, Ian
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Stiefel, Gary
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Thomas, Huw M.
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SNIFFLE-4 Study Investigators (2019) Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma. Journal of Allergy and Clinical Immunology, 145 (4), 1157-1164.e6. (doi:10.1016/j.jaci.2019.12.010).

Record type: Article

Abstract

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.

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Accepted/In Press date: 12 December 2019
Published date: 18 December 2019
Keywords: Asthma, children, immunization, influenza, live attenuated influenza vaccine

Identifiers

Local EPrints ID: 444742
URI: http://eprints.soton.ac.uk/id/eprint/444742
ISSN: 0091-6749
PURE UUID: 83fe38a3-f908-4bd7-9654-29016464945d
ORCID for Michel Erlewyn-Lajeunesse: ORCID iD orcid.org/0000-0003-1982-1397
ORCID for Graham Roberts: ORCID iD orcid.org/0000-0003-2252-1248

Catalogue record

Date deposited: 03 Nov 2020 17:30
Last modified: 10 Jan 2022 03:15

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Contributors

Author: Paul J. Turner
Author: Louise Fleming
Author: Sejal Saglani
Author: Jo Southern
Author: Nick J. Andrews
Author: Elizabeth Miller
Author: Alexandra Adams
Author: Christine Doyle
Author: Michel Erlewyn-Lajeunesse ORCID iD
Author: Katy Fidler
Author: Atul Gupta
Author: Stephen M. Hughes
Author: Andrew Ives
Author: Nicola Jay
Author: Sonal Kansra
Author: Louise Michaelis
Author: Samantha Moss
Author: Clare Murray
Author: Prasad Nagakumar
Author: Graham Roberts ORCID iD
Author: Paul Seddon
Author: Ian Sinha
Author: Gary Stiefel
Author: Huw M. Thomas
Corporate Author: SNIFFLE-4 Study Investigators

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