TY - JOUR
T1 - Safe administration of the seasonal trivalent influenza vaccine to children with severe egg allergy
AU - Greenhawt, Matthew J.
AU - Spergel, Jonathan M.
AU - Rank, Matthew A.
AU - Green, Todd D.
AU - Masnoor, Darlene
AU - Sharma, Hemant
AU - Bird, J. Andrew
AU - Chang, Jinny E.
AU - Sinh, Divya
AU - Teich, Esther
AU - Kelso, John M.
AU - Sanders, Georgiana M.
N1 - Funding Information:
Funding Sources: Dr Greenhawt received support to conduct the trial from the American College of Allergy, Asthma, and Immunology 2010 Young Faculty Award and was supported in part by a grant number UL1RR024986 from the National Center for Research Resources .
PY - 2012/12
Y1 - 2012/12
N2 - Background: Anaphylaxis to egg or severe egg allergy has been considered a contraindication to receiving trivalent seasonal influenza vaccine (TIV). Objective: To evaluate the safety of TIV among severely egg allergic children. Methods: A 2-phase, multicenter study at 7 sites was conducted between October 2010 and March 2012. Inclusion criteria included a history of a severe reaction, including anaphylaxis, to the ingestion of egg and a positive skin test result or evidence of serum specific IgE antibody to egg. Phase 1 consisted of a randomized, prospective, double-blind, placebo controlled trial of TIV administration to egg allergic children, using a 2-step approach; group A received 0.1 mL of influenza vaccine, followed in 30 minutes if no reaction with the remainder of an age-appropriate dose, whereas group B received an injection of normal saline followed in 30 minutes if no reaction with the full 100% of the age-appropriate dose. Phase 2 was a retrospective analysis of single dose vs split-dose administration of TIV in eligible study participants who declined participation in the randomized controlled trial. Results: Thirty-one study participants were prospectively evaluated in the randomized controlled trial (group A, 14; group B, 17); 45.1% had a history of anaphylaxis after egg ingestion. A total of 112 participants were retrospectively evaluated (87 with the single dose and 25 with the split dose); 77.6% of participants had a history of anaphylaxis after egg ingestion. All participants in both phases received TIV without developing an allergic reaction. Conclusion: TIV administration is safe even in children with histories of severe egg allergy. Use of 2-step split dosing appears unnecessary because a single dose was well tolerated.
AB - Background: Anaphylaxis to egg or severe egg allergy has been considered a contraindication to receiving trivalent seasonal influenza vaccine (TIV). Objective: To evaluate the safety of TIV among severely egg allergic children. Methods: A 2-phase, multicenter study at 7 sites was conducted between October 2010 and March 2012. Inclusion criteria included a history of a severe reaction, including anaphylaxis, to the ingestion of egg and a positive skin test result or evidence of serum specific IgE antibody to egg. Phase 1 consisted of a randomized, prospective, double-blind, placebo controlled trial of TIV administration to egg allergic children, using a 2-step approach; group A received 0.1 mL of influenza vaccine, followed in 30 minutes if no reaction with the remainder of an age-appropriate dose, whereas group B received an injection of normal saline followed in 30 minutes if no reaction with the full 100% of the age-appropriate dose. Phase 2 was a retrospective analysis of single dose vs split-dose administration of TIV in eligible study participants who declined participation in the randomized controlled trial. Results: Thirty-one study participants were prospectively evaluated in the randomized controlled trial (group A, 14; group B, 17); 45.1% had a history of anaphylaxis after egg ingestion. A total of 112 participants were retrospectively evaluated (87 with the single dose and 25 with the split dose); 77.6% of participants had a history of anaphylaxis after egg ingestion. All participants in both phases received TIV without developing an allergic reaction. Conclusion: TIV administration is safe even in children with histories of severe egg allergy. Use of 2-step split dosing appears unnecessary because a single dose was well tolerated.
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U2 - 10.1016/j.anai.2012.09.011
DO - 10.1016/j.anai.2012.09.011
M3 - Article
C2 - 23176882
AN - SCOPUS:84869882661
SN - 1081-1206
VL - 109
SP - 426
EP - 430
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 6
ER -