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

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.

SUBMITTER: Turner PJ

PROVIDER: S-EPMC7156909 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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

Turner Paul J PJ Fleming Louise L Saglani Sejal S Southern Jo J Andrews Nick J NJ Miller Elizabeth E

The Journal of allergy and clinical immunology 20191218 4

<h4>Background</h4>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.<h4>Objective</h4>We sought to assess the safety of LAIV in children with moderate to severe asthma, and in preschool children with recurrent wheeze.<h4>Methods</h4>Prospective, multicenter, open-label, phase IV i ...[more]

PMID: 31863808

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Project description:LAIV and TIV are effective for prevention of influenza infection in children, but the mechanisms associated with protection are still not well defined. We analyzed the differences in B cell responses and transcriptional profiles. Compared to baseline, LAIV elicited a significant increase in naM-CM-/ve, memory and transitional B cells on day 30, while vaccination with TIV elicited an increase in number of plasmablasts on day 7. Antibody titers against the three vaccine strains (H1N1, H3N2 and B) were significantly higher in the TIV group and correlated with number of antibody-secreting cells. Regarding transcriptional profiles, both vaccines induced expression of interferon signaling, but at different time points, TIV on 1 day, and LAIV on day 7 day post-vaccination, the last only in children younger than 5 years old. Interferon-related genes over expressed in both vaccinated groups correlated with antibody titers of H3N2 vaccines strain. These results suggest that LAIV and TIV induced significant different B cell responses in vaccinated children. Early induction on interferon genes appears important for development of effective antibody responses. Longitudinal study with time points at baseline (day 0), 24hr, day 7 and day 30. 136 total samples analyzed. This was a prospective cohort of previously healthy children 6 months to 14 years of age enrolled between October 2011 and February 2012. Thirty seven subjects were randomized to receive one dose of either LAIV (FluMistM-BM-., MedImmune) (n= 20) or TIV (FluzoneM-BM-., Sanofi Pasteur) (n= 17). Two exceptions were applied to the randomization: four children with ages between 6 months and 2 years old received TIV, since LAIV is not licensed on this age group, and four children with controlled asthma also received TIV following CDCM-bM-^@M-^Ys recommendations. One child aged 6 months at the time of enrollment received two doses of the vaccine with one month interval apart, since it was his first influenza vaccination. Exclusion criteria included any medical comorbidities or chronic conditions (lung, kidney or heart disease), use of systemic steroids in the previous 2 weeks, and congenital or acquired immunodeficiencies. The 2011-2012 LAIV and TIV vaccines contained A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like and B/Brisbane/60/2008-like antigens, the same strains used on the 2010-2011 influenza vaccine. TIV recipients aged 6 to 35 months old received 0.25 mL intramuscularly and recipients aged 36 months and older received 0.5 mL. LAIV recipients received 0.2 mL by intranasal route, 0.1 mL per nostril. Blood samples were collected at four time points, on day zero prior to vaccination, and day 1, day 7 (range 6-8) and day 30 (range 27-33) post-vaccination.

Project description:OBJECTIVES:To assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups. DESIGN:Non-interventional cohort study. SETTING:England during 2013-2014 and 2014-2015 influenza seasons. PARTICIPANTS:LAIV recipients identified from the Clinical Practice Research Datalink, aged 2-17 years, and with at least one underlying high-risk condition. LAIV recipients were matched with inactivated influenza vaccine (IIV) recipients and unvaccinated controls. PRIMARY OUTCOME MEASURES:Primary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination. RESULTS:11 463 children and adolescents were included: 4718 received the trivalent LAIV formulation during the 2013-2014 influenza season and 6745 received the quadrivalent formulation during the 2014-2015 influenza season. The risks of hospitalisation within 42 days were 231 per 1000 person-years (95% CI 193 to 275) in season 2013-2014 and 231 (95% CI 198 to 267) in season 2014-2015. These risks were not significantly different when compared with matched unvaccinated children (relative risks (RR) 0.96 (95% CI 0.78 to 1.19) in season 2013-2014, 0.90 (95% CI 0.76 to 1.07) in season 2014-2015) and consistently lower than after IIV administration (RR 0.47 (95% CI: 0.37 to 0.59) in season 2013-2014, 0.42 (95% CI 0.35 to 0.51) in season 2014-2015). A similar pattern was observed up to 6 months postvaccination with a risk of hospitalisation after LAIV administration that did not differ from what was observed in unvaccinated controls and was lower than after IIV administration. CONCLUSIONS:This study did not identify new safety concerns associated with the administration of LAIV in children and adolescents with high-risk conditions. However, as with any other observational study, treatment administration was not randomly assigned and our findings may be confounded by differences between the groups at baseline. TRIAL REGISTRATION NUMBER:EUPAS18527.

Dataset Information

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

Publications

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

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