tetano
Editor, Senior Moderator
J Allergy Clin Immunol. 2019 Dec 18. pii: S0091-6749(19)31712-9. doi: 10.1016/j.jaci.2019.12.010. [Epub ahead of print] [h=1]Safety of Live Attenuated Influenza Vaccine in Children with Moderate-Severe Asthma.[/h]
Turner PJ[SUP]1[/SUP], Fleming L[SUP]2[/SUP], Saglani S[SUP]2[/SUP], Southern J[SUP]3[/SUP], Andrews NJ[SUP]3[/SUP], Miller E[SUP]3[/SUP]; SNIFFLE-4 Study Investigators.
[h=3]Author information[/h] 1 Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom; Immunisation, Hepatitis and Blood Safety Department, Public Health England, London, United Kingdom. Electronic address: p.turner@imperial.ac.uk. 2 Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom. 3 Immunisation, Hepatitis and Blood Safety Department, Public Health England, London, United Kingdom.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] To assess the safety of LAIV in children with moderate-severe asthma, and in preschool children with recurrent wheeze.
[h=4]METHODS:[/h] Prospective, multi-center, 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. ClinicalTrials.gov registration NCT02866942, EU Clinical Trials registration 2016-002352-24.
[h=4]RESULTS:[/h] 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 following administration (median change 0, P=.26, McNemar's test), with no impact of level of baseline asthma control/symptoms in predicting either a worsening of asthma or exacerbation following LAIV using a regression model. 47 subjects (14.7%, 95%CI 11% to 19.1%) reported a severe asthma exacerbation in the four weeks following immunization, requiring short course of systemic corticosteroids; in four cases, this occurred within 72 hours of vaccine. No association with asthma severity, baseline lung function or asthma control was identified.
[h=4]CONCLUSIONS:[/h] 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.
Copyright ? 2019. Published by Elsevier Inc.
[h=4]KEYWORDS:[/h] Asthma; Live attenuated influenza vaccine; children; immunization; influenza
PMID: 31863808 DOI: 10.1016/j.jaci.2019.12.010
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Turner PJ[SUP]1[/SUP], Fleming L[SUP]2[/SUP], Saglani S[SUP]2[/SUP], Southern J[SUP]3[/SUP], Andrews NJ[SUP]3[/SUP], Miller E[SUP]3[/SUP]; SNIFFLE-4 Study Investigators.
[h=3]Author information[/h] 1 Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom; Immunisation, Hepatitis and Blood Safety Department, Public Health England, London, United Kingdom. Electronic address: p.turner@imperial.ac.uk. 2 Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, London, United Kingdom. 3 Immunisation, Hepatitis and Blood Safety Department, Public Health England, London, United Kingdom.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] To assess the safety of LAIV in children with moderate-severe asthma, and in preschool children with recurrent wheeze.
[h=4]METHODS:[/h] Prospective, multi-center, 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. ClinicalTrials.gov registration NCT02866942, EU Clinical Trials registration 2016-002352-24.
[h=4]RESULTS:[/h] 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 following administration (median change 0, P=.26, McNemar's test), with no impact of level of baseline asthma control/symptoms in predicting either a worsening of asthma or exacerbation following LAIV using a regression model. 47 subjects (14.7%, 95%CI 11% to 19.1%) reported a severe asthma exacerbation in the four weeks following immunization, requiring short course of systemic corticosteroids; in four cases, this occurred within 72 hours of vaccine. No association with asthma severity, baseline lung function or asthma control was identified.
[h=4]CONCLUSIONS:[/h] 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.
Copyright ? 2019. Published by Elsevier Inc.
[h=4]KEYWORDS:[/h] Asthma; Live attenuated influenza vaccine; children; immunization; influenza
PMID: 31863808 DOI: 10.1016/j.jaci.2019.12.010
Free full text