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FluMist in Egg Allergic Patients (FluEMIST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Texas
University of South Alabama
University of Michigan
Scripps
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT01248208
First received: November 24, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 influenza virus. The only individuals not able to receive this vaccination in the primary care provider's office are those patients with egg allergies and, in rare circumstances, individuals with allergies to other components of the vaccine. Current guidelines allow for the administration of the influenza vaccine to patients with egg allergy using vaccines with low egg protein (ovalbumin) content or by using skin testing followed by a 5-dose desensitization protocol. Since this is impractical to perform in the primary care office and cumbersome for allergists, many egg-allergic patients simply do not receive the influenza vaccine, leaving them more vulnerable to the disease and more likely to become a source of contagion.

Several studies have suggested that influenza vaccination using a 1-2 dose protocol may be safe. This fact is due in large part to the low ovalbumin (egg protein) content in modern influenza vaccines. All studies of influenza vaccination in egg-allergic patients have been done using intramuscular trivalent inactivated influenza vaccine (TIV). However, the trivalent live-attenuated, cold-adapted influenza vaccine (LAIV), which is delivered intranasally, has a lower published ovalbumin content than the injectable vaccines, suggesting that it may also be well-tolerated by egg-allergic patients. According to several studies, LAIV may be more efficacious than TIV in children.

It is the goal of the investigators to evaluate the safety of immunizing egg-allergic individuals with the LAIV.


Condition Intervention Phase
Egg Allergy
Eligible for Vaccination Against Influenza
Biological: FluMist intranasal influenza vaccine
Biological: Intramuscular influenza injection ("flu shot")
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Flu Vaccine in Egg-allergic Patients Minimizing Injections Safety Trial

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • To estimate the safety of LAIV in egg-allergic patients receiving the LAIV. [ Time Frame: within 48 hours after vaccine administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the safety of a single, full-strength dose of TIV in egg allergic patients. [ Time Frame: Within 48 hours of vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FluMist (LAIV) group
Patients age 2-49 years WITHOUT a history of asthma symptoms or treatment within the past 12 months will receive intranasal FluMist.
Biological: FluMist intranasal influenza vaccine
FluMist intranasal vaccine 0.2 mL will be given 0.1 mL in each nostril per manufacturer's instructions.
Experimental: Flu shot (TIV) group

Patients 6 months to 2 yrs or > 49 years or WITH a history of asthma symptoms / treatment within the past 12 months will receive intramuscular influenza vaccination. 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.
Biological: Intramuscular influenza injection ("flu shot")

Subjects < 2 years or > 49 years or those with asthma symptoms or treatment within the past year will receive the intramuscular flu shot in a single injection.

Age 6-36 months: 0.25 mL IM x 1; Age >36 months: 0.5 mL IM x 1 Boosters: All children aged 6 months-8 years who receive a seasonal influenza vaccine for the first time should be administered 2 doses. Children aged 6 months-8 years who received a seasonal vaccine for the first time during 2009-2010 but who received only 1 dose should receive 2 doses, rather than 1, during 2010-2011. In addition, for the 2010-11 influenza season, children aged 6 months-8 years who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine should receive 2 doses of a 2010-11 seasonal influenza vaccine, regardless of previous influenza vaccination history. For all children, the second dose of a recommended 2-dose series should be administered 4 or more weeks after the initial dose.

Other Names:
  • Fluzone (approved for children down to 6 months)
  • Fluvirin (age 4y and older)
  • Agriflu (age 18y and older)
  • Fluarix (age 3y and older)
  • FluLaval (age 18y and older)
  • Afluria (age 9y and older)

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 influenza vaccines on the market, those who are eligible to receive the intranasal formulation (LAIV group) (ie age 2-49y, not asthmatic) will receive FluMist; others will receive the intramuscular injection in a single dose without skin testing (TIV group). All subjects will be monitored for 30 minutes post-vaccine for any signs/symptoms of an immediate allergic reaction. Subjects will also be followed-up by phone 24-48 hours after administration to assess for any delayed allergic reaction. Data will be collected for one entire Influenza season (2010-2011).

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248208

Contacts
Contact: Kristi McKinney, MD 202-782-6848 kristi.mckinney@us.army.mil
Contact: Susan Laubach, MD 202-782-9471 susan.laubach@us.army.mil

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Kristi McKinney, MD    202-782-6848    kristi.mckinney@us.army.mil   
Contact: Susan Laubach, MD    202-782-9471    susan.laubach@us.army.mil   
Principal Investigator: Kristi McKinney, MD         
Sub-Investigator: Susan Laubach, MD         
Sponsors and Collaborators
Walter Reed Army Medical Center
University of Texas
University of South Alabama
University of Michigan
Scripps
Investigators
Study Director: Susan Laubach, MD Walter Reed Army Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Laubach, MD, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT01248208     History of Changes
Other Study ID Numbers: 357349
Study First Received: November 24, 2010
Last Updated: November 24, 2010
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
egg allergy
influenza vaccine

Additional relevant MeSH terms:
Egg Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014