FluMist in Egg Allergic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01248208
• Date of registration: 24/11/2010
• Primary sponsor: Walter Reed Army Medical Center
• Public title: FluMist in Egg Allergic Patients FluEMIST
• Scientific title: Flu Vaccine in Egg-allergic Patients Minimizing Injections Safety Trial
• Date of first enrolment: September 2010
• Target sample size: 200
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01248208
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Kristi McKinney, MD

• Name: Kristi McKinney, MD

• Name: Susan Laubach, MD
• Affiliation: Walter Reed Army Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

1. wheezing in the past 12 months

2. use of inhaled corticosteroids (ICS), combined ICS / long acting beta agonist
(LABA), or oral steroid in the past 12 months

3. emergency room or acute care visit or hospitalization for asthma or wheezing in
the past 12 months.

Exclusion Criteria:

- 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:

1. H1 antihistamines or doxepin should be discontinued for 7 days, and
diphenhydramine for 72 hrs prior.

2. H2 antihistamines should be discontinued for 24 hrs prior.

3. Tricyclic antidepressants should be discontinued, after consultation with the
prescribing physician, for 6 weeks prior.

4. Beta blockers should be discontinued, after consultation with the prescribing
physician, for 24 hours prior.



Age minimum: 6 Months
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Egg Allergy

Eligible for Vaccination Against Influenza

Intervention(s)

Biological: FluMist intranasal influenza vaccine

Biological: Intramuscular influenza injection ("flu shot")

Primary Outcome(s)

To estimate the safety of LAIV in egg-allergic patients receiving the LAIV. [Time Frame: within 48 hours after vaccine administration]

Secondary Outcome(s)

To estimate the safety of a single, full-strength dose of TIV in egg allergic patients. [Time Frame: Within 48 hours of vaccination]

Secondary ID(s)

357349

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Scripps

University of Michigan

University of South Alabama

University of Texas