N/A N=31 Randomized Triple-blind Treatment

Safe Administration of Flu Vaccine to Egg Allergic Children

Egg Allergy

Bottom Line

View on ClinicalTrials.gov: NCT01264601 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Categorical Reactivity to Vaccine as it Was Administered — 17; 14; 3; 4 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Trivalent Influenza Vaccine (Biological)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Categorical Reactivity to Vaccine as it Was Administered	17; 14; 3; 4	—
SECONDARY Influence of Atopic Co-morbidities on Severe Reactivity to Vaccine as it Was Administered	—	—

Summary

Historically, providing influenza vaccination of egg allergic children and young adults (EAC) with a history of anaphylaxis to egg, or other severe symptoms of an allergic reaction to egg (e.g., severe hives, swelling, or asthma), has been contra-indicated, though vaccination of children with less severe egg allergy has been shown to be safe. Though many children with severe egg allergy, including anaphylaxis, have received past influenza vaccination anecdotally, very few data exist to show this procedure is safe. The investigators propose a double blind, placebo-controlled randomized, prospective multi-centered study to a) demonstrate seasonal trivalent influenza vaccine (TIV) can be safely given in a single dose (as opposed to through 2-step graded dosing of 10% then 90% of the vaccine dose) to EAC despite history of anaphylaxis or previous severe allergic reaction to egg; and b) provide further evidence that adverse outcomes are not related to ovalbumin (egg) content in TIV. Study participants must have a documented history of a severe egg allergy, substantiated by both a history of clinical reactivity AND either a positive skin test or ImmunoCAP/RAST test greater than 0.7 kUA/L. Participants will be randomized to receive either a 2-step graded challenge or a single dose given after a small placebo dose of saline (to mimic the graded challenge). If required, all participants will receive a booster vaccination as a single dose.

Eligibility Criteria

Inclusion Criteria

Ages 6 months-24 years, seen in the UMHS Allergy Clinics (and similar academic Allergy clinics of collaborating sites) in the last 24 months with a discharge diagnosis code of v15.03 indicating an of egg allergy, AND with correlated history including the following:
Egg allergy as defined by:

Positive egg challenge; OR strong history suggestive of clinical allergy within 4 hours of ingestion AND egg-specific IgE above 0.70 kUA/L OR wheal 3mm > control (or 2+ score if wheal size not available).

Anaphylaxis after egg ingestion, defined by:

Patients with a verified history (by chart review) of their single most severe reaction to egg resulting in the following, per NIAID/FAAN 2006 criteria:5 i) Acute onset of an illness with involvement of the skin/mucosal tissue (e.g., generalized hives, pruritus or flushing, swollen lips-tongue-uvula) AND EITHER respiratory compromise (e.g., dyspnea, wheezing/bronchospasm, stridor, reduced peek expiratory flow) OR reduced blood pressure or associated symptoms (eg, hypotonia or syncope); OR ii) Two or more of the following after exposure to an allergen: involvement of the skin/mucosal tissue (e.g., urticaria, itching/flushing, swollen lips/tongue/uvula); respiratory compromise (e.g., dyspnea, wheezing/bronchospasm, stridor, reduced peak expiratory flow); reduced blood pressure or associated symptoms (e.g., hypotonia or syncope); or persistent gastrointestinal symptoms (e.g., crampy abdominal pain or vomiting); OR iii) Hypotension after exposure to known allergen for that patient c) A severe allergic reaction will be defined by a history of development of severe hives, angioedema, or allergic asthma attributable to egg allergy.

Subject must fulfill criteria for both egg allergy and for either anaphylaxis or a severe allergic reaction (both attributable to egg) to be included in the study, i.e. both (a) and either (b) or (c).
Ability to remain off antihistamines for at least 5 days prior to the study visit, for skin testing.
For children, the ability to remain in the exam room for the duration of the testing visit.
Previous history of TIV of H1N1 vaccination is neither inclusive nor exclusive for the study.

Exclusion Criteria

Does not fulfill requirements for both egg allergy AND anaphylaxis or severe allergic reaction.
Prolonged use of immunosuppressive medication, including high dose corticosteroids > 6 months, as well as other immunosuppressive agents.
Prior history of egg allergy, now outgrown and tolerating egg ingestion.
Eosinophilic esophagitis.
Cardiac disease.
Known malignancy under treatment.
Pregnant women.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01264601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.