Status:
COMPLETED
Safe Administration of Flu Vaccine to Egg Allergic Children
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
American College of Allergy, Asthma and Immunology
Conditions:
Egg Allergy
Eligibility:
All Genders
6-24 years
Phase:
NA
Brief 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., sever...
Detailed Description
Seasonal Trivalent Influenza Vaccine (TIV) is grown in embryonated chicken eggs, and since it contains residual egg protein (ovalbumin), providing TIV to egg allergic children (EAC) could potentially ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01264601
Start Date
October 1 2010
End Date
August 1 2012
Last Update
October 26 2017
Active Locations (5)
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1
Scripps Clinic
San Diego, California, United States, 92130
2
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48106
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224