Safe Administration of Flu Vaccine to Egg Allergic Children (SAFE)
Egg Allergy
About this trial
This is an interventional treatment trial for Egg Allergy focused on measuring Anaphylaxis to Egg, Severe Egg Allergy
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.
Sites / Locations
- Scripps Clinic
- University of Michigan Health Systems
- Mayo Clinic
- Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center
- Children's Medical Center Dallas, University of Texas-Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Single Dose
Graded Challenge
This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.
Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.