Safety of live attenuated influenza vaccine in atopic children with egg allergy

Paul J Turner, Jo Southern, Nick J Andrews, Elizabeth Miller, Michel Erlewyn-Lajeunesse, SNIFFLE Study Investigators, Christine Doyle, George Du Toit, Michel Erlewyn-Lajeunesse, Roisin Fitzsimons, Paul T Heath, Stephen M Hughes, Louise Michealis, Jürgen Schwarz, Matthew D Snape, Gary Stiefel, Huw M Thomas, Paul J Turner, Paul J Turner, Jo Southern, Nick J Andrews, Elizabeth Miller, Michel Erlewyn-Lajeunesse, SNIFFLE Study Investigators, Christine Doyle, George Du Toit, Michel Erlewyn-Lajeunesse, Roisin Fitzsimons, Paul T Heath, Stephen M Hughes, Louise Michealis, Jürgen Schwarz, Matthew D Snape, Gary Stiefel, Huw M Thomas, Paul J Turner

Abstract

Background: Live attenuated influenza vaccine (LAIV) is an intranasal vaccine recently incorporated into the United Kingdom immunization schedule. However, it contains egg protein and, in the absence of safety data, is contraindicated in patients with egg allergy. Furthermore, North American guidelines recommend against its use in asthmatic children.

Objective: We sought to assess the safety of LAIV in children with egg allergy.

Methods: We performed a prospective, multicenter, open-label, phase IV intervention study involving 11 secondary/tertiary centers in the United Kingdom. Children with egg allergy (defined as a convincing clinical reaction to egg within the past 12 months and/or >95% likelihood of clinical egg allergy as per published criteria) were recruited. LAIV was administered under medical supervision, with observation for 1 hour and telephone follow-up 72 hours later.

Results: Four hundred thirty-three doses were administered to 282 children with egg allergy (median, 4.9 years; range, 2-17 years); 115 (41%) had experienced prior anaphylaxis to egg. A physician's diagnosis of asthma/recurrent wheezing was noted in 67%, and 51% were receiving regular preventer therapy. There were no systemic allergic reactions (upper 95% CI for population, 1.3%). Eight children experienced mild self-limiting symptoms, which might have been due an IgE-mediated allergic reaction. Twenty-six (9.4%; 95% CI for population, 6.2% to 13.4%) children experienced lower respiratory tract symptoms within 72 hours, including 13 with parent-reported wheeze. None of these episodes required medical intervention beyond routine treatment.

Conclusions: In contrast to current recommendations, LAIV appears to be safe for use in children with egg allergy. Furthermore, the vaccine appears to be well tolerated in children with a diagnosis of asthma or recurrent wheeze.

Trial registration: ClinicalTrials.gov NCT01859039.

Keywords: Egg allergy; asthma; live attenuated influenza vaccine; recurrent wheezing; safety.

Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Figures

Fig 1
Fig 1
Patient flow diagram. *One child could not receive LAIV because a family member had commenced immunosuppressant therapy for medical reasons. This child was given IIV instead.

References

    1. Eggesbo M., Botten G., Halvorsen R., Magnus P. The prevalence of allergy to egg: a population-based study in young children. Allergy. 2001;56:403–411.
    1. Des Roches A., Paradis L., Gagnon R., Lemire C., Bégin P., Carr S. Egg-allergic patients can be safely vaccinated against influenza. J Allergy Clin Immunol. 2012;130:1213–1216.e1.
    1. Gagnon R., Primeau M.N., Des Roches A., Lemire C., Kagan R., Carr S. Safe vaccination of patients with egg allergy with an adjuvanted pandemic H1N1 vaccine. J Allergy Clin Immunol. 2010;126:317–323.
    1. Erlewyn-Lajeunesse M., Lucas J.S., Warner J.O. Influenza immunization in egg allergy: an update for the 2011-2012 season. Clin Exp Allergy. 2011;41:1367–1370.
    1. Kelso J.M., Greenhawt M.J., Li J.T., Nicklas R.A., Bernstein D.I., Blessing-Moore J. Adverse reactions to vaccines practice parameter 2012 update. J Allergy Clin Immunol. 2012;130:25–43.
    1. Grohskopf L.A., Olsen S.J., Sokolow L.Z., Bresee J.S., Cox N.J., Broder K.R. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2014-15 Influenza Season. MMWR Morb Mortal Wkly Rep. 2014;63:691–697.
    1. Osterholm M.T., Kelley N.S., Sommer A., Belongia E.A. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12:36–44.
    1. Ambrose C.S., Wu X., Knuf M., Wutzler P. The efficacy of intranasal live attenuated influenza vaccine in children 2 through 17 years of age: a meta-analysis of 8 randomized controlled studies. Vaccine. 2012;30:886–892.
    1. Fleming D.M., Crovari P., Wahn U., Klemola T., Schlesinger Y., Langussis A. Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J. 2006;25:860–869.
    1. Belshe R.B., Edwards K.M., Vesikari T., Black S.V., Walker R.E., Hultquist M. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007;356:685–696.
    1. Ambrose C.S., Dubovsky F., Yi T., Belshe R.B., Ashkenazi S. The safety and efficacy of live attenuated influenza vaccine in young children with asthma or prior wheezing. Eur J Clin Microbiol Infect Dis. 2012;31:2549–2557.
    1. Tennis P., Toback S.L., Andrews E., McQuay L.J., Ambrose C.S. A postmarketing evaluation of the frequency of use and safety of live attenuated influenza vaccine use in non-recommended children younger than 5 years. Vaccine. 2011;29:4947–4952.
    1. Tennis P., Toback S.L., Andrews E.B., McQuay L.J., Ambrose C.S. A US postmarketing evaluation of the frequency and safety of live attenuated influenza vaccine use in non-recommended children younger than 5 years: 2009-2010 season. Vaccine. 2012;30:6099–6102.
    1. Baxter R., Toback S.L., Sifakis F., Hansen J., Bartlett J., Aukes L. A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age. Vaccine. 2012;30:2989–2998.
    1. Belshe R.B., Ambrose C.S., Yi T. Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age. Vaccine. 2008;26(suppl 4):D10–D16.
    1. Gaglani M.J., Piedra P.A., Riggs M., Herschler G., Fewlass C., Glezen W.P. Safety of the intranasal, trivalent, live attenuated influenza vaccine (LAIV) in children with intermittent wheezing in an open-label field trial. Pediatr Infect Dis J. 2008;27:444–452.
    1. Public Health England. Chapter 19: Influenza. In: Immunisation against infectious disease. Department of Health. Available at: . Accessed September 30, 2014.
    1. Hill D.J., Heine R.G., Hosking C.S. The diagnostic value of skin prick testing in children with food allergy. Pediatr Allergy Immunol. 2004;15:435–441.
    1. World Allergy Organization guidelines for the assessment and management of anaphylaxis. WAO J. 2011;4:13–37.
    1. British Thoracic Society and Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma: a national clinical guideline. Available at: . Accessed September 30, 2014.
    1. Sampson H.A., Gerth van Wijk R., Bindslev-Jensen C., Sicherer S., Teuber S.S., Burks A.W. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012;130:1260–1274.
    1. Bousquet P.J., Combescure C., Klossek J.M., Daures J.P., Bousquet J. Change in visual analog scale score in a pragmatic randomized cluster trial of allergic rhinitis. J Allergy Clin Immunol. 2009;123:1349–1354.
    1. Hilberg O. Objective measurement of nasal airway dimensions using acoustic rhinometry: methodological and clinical aspects. Allergy. 2002;57(suppl 70):5–39.
    1. Ruggeberg J.U., Gold M.S., Bayas J.M., Blum M.D., Bonhoeffer J., Friedlander S. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25:5675–5684.
    1. Des Roches A., Samaan K., Graham F., Lacombe-Barrios J., Paradis J., Paradis L. Safe vaccination of egg allergic patients with live attenuated influenza vaccine. J Allergy Clin Immunol Pract. 2014;3:138–139.
    1. Toback S.L., Ambrose C.S., Eaton A., Hansen J., Aukes L., Lewis N. A postlicensure evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 24-59 months of age. Vaccine. 2013;31:1812–1818.
    1. Izurieta H.S., Haber P., Wise R.P., Iskander J., Pratt D., Mink C. Adverse events reported following live, cold-adapted, intranasal influenza vaccine. JAMA. 2005;294:2720–2725.
    1. Goldis M.E., Bardina L., Gimenez G., Lin J., Sampson H.A. Evaluation of flu vaccines with regard to their egg protein content. Pediatr Allergy Immunol. 2011;22:642–643.
    1. McKinney K.K., Webb L., Petersen M., Nelson M., Laubach S. Ovalbumin content of 2010-2011 influenza vaccines. J Allergy Clin Immunol. 2011;127:1629–1632.
    1. Fluenz Tetra—summary of product characteristics. Available at: . Accessed September 30, 2014.
    1. Turner P.J., Erlewyn-Lajeuness M. Egg Protein in the intranasal live-attenuated influenza vaccine (LAIV) is unlikely to cause egg-mediated allergic reactions in egg-allergic children. J Allergy Clin Immunol Pract. 2015;136:376–381.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner