Status:
COMPLETED
FluMist in Egg Allergic Patients
Lead Sponsor:
Walter Reed Army Medical Center
Collaborating Sponsors:
University of Texas
University of South Alabama
Conditions:
Egg Allergy
Eligible for Vaccination Against Influenza
Eligibility:
All Genders
6+ years
Phase:
PHASE1
PHASE2
Brief Summary
With the growing public health concerns of seasonal influenza and H1N1 in the United States, the primary means by which this can be addressed is with prevention, namely, vaccination against the influe...
Detailed Description
Patients with egg allergy will be recruited into the study. Since the trivalent live-attenuated, cold-adapted influenza vaccine (LAIV) contains the lowest amount of egg protein of all available influe...
Eligibility Criteria
Inclusion
- Age \> 6 months
- Clinical history of allergic symptoms (hives, swelling, vomiting, respiratory problems, low blood pressure) within 2 hours after ingestion of egg OR Eczema/atopic dermatitis worsened by egg exposure
- Confirmation of clinical history by positive egg skin prick test or serum egg-specific IgE or a positive oral food challenge. \[The \>95% positive predictive values of egg serum IgE in subjects \>2 years old with atopic dermatitis is 6 kU/L or greater. In subjects \>2 years old without atopic dermatitis, the value is 7 kU/L or greater. In subjects less than 2 years old, the value is 2 kU/L or greater.\]
- FluMist (LAIV) cohort: Patients age 2-49 years WITHOUT a history of asthma symptoms or treatment within the past 12 months will receive intranasal FluMist.
- Flu Shot (TIV) Intramuscular influenza vaccine cohort: Patients 6 months to 2 yrs or \> 49 years or WITH a history of asthma symptoms / treatment within the past 12 months. History/Treatment of asthma in the past 12 months is defined as follows:
- wheezing in the past 12 months
- use of inhaled corticosteroids (ICS), combined ICS / long acting beta agonist (LABA), or oral steroid in the past 12 months
- emergency room or acute care visit or hospitalization for asthma or wheezing in the past 12 months.
Exclusion
- Subjects who potentially have outgrown their egg allergy (no allergic reaction with ingestion of whole egg in the past 18 months and an egg serum specific IgE level ≤2 kU/L).
- Pregnancy
- Current moderate to severe illness with a fever.
- Allergy to other components of the vaccine - gentamicin, gelatin, arginine, thimerosal - or a history of a previous allergic reaction to the influenza vaccine.
- Abnormal Vital Signs.
- History of Guillain-Barre' Syndrome (GBS).
- HIV/AIDS or another disease that affects the immune system, or cancer.
- Long term health problems that are contraindicated for the LAIV or TIV.
- Receipt of a live viral vaccine within the month prior (e.g. FluMist, MMR, yellow fever, chicken pox, rotavirus, smallpox).
- Current use of any prescription medicine (e.g. antiviral) to prevent or treat influenza. (only excludes use of LAIV, may still receive TIV)
- Concurrent use of aspirin or aspirin-containing therapy in children and adolescents (2-18 years of age)(only excludes use of LAIV, may still receive TIV)
- Living with or having close contact with someone whose immune system is severely compromised (e.g. transplant recipient). (only excludes use of LAIV, may still receive TIV) Breastfeeding mothers may still receive either LAIV or TIV.
- The following medications can interfere with signs of an allergic reaction or complicate the treatment of an allergic reaction and should be discontinued as outlined below:
- H1 antihistamines or doxepin should be discontinued for 7 days, and diphenhydramine for 72 hrs prior.
- H2 antihistamines should be discontinued for 24 hrs prior.
- Tricyclic antidepressants should be discontinued, after consultation with the prescribing physician, for 6 weeks prior.
- Beta blockers should be discontinued, after consultation with the prescribing physician, for 24 hours prior.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01248208
Start Date
September 1 2010
End Date
October 1 2012
Last Update
October 3 2018
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307