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FluMist in Egg Allergic Patients (FluEMIST)

Primary Purpose

Egg Allergy, Eligible for Vaccination Against Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

FluMist intranasal influenza vaccine

Intramuscular influenza injection ("flu shot")

About this trial

This is an interventional prevention trial for Egg Allergy focused on measuring egg allergy, influenza vaccine

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FluMist (LAIV) group

Flu shot (TIV) group

Arm Description

FluMist influenza vaccine 0.2 mL intranasal vaccine once

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: 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.

Outcomes

Primary Outcome Measures

To estimate the safety of LAIV in egg-allergic patients receiving the LAIV.

Secondary Outcome Measures

To estimate the safety of a single, full-strength dose of TIV in egg allergic patients.

Full Information

NCT ID

NCT01248208

First Posted

November 24, 2010

Last Updated

October 1, 2018

Sponsor

Walter Reed Army Medical Center

Collaborators

University of Texas, University of South Alabama, University of Michigan, Scripps Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01248208

Brief Title

FluMist in Egg Allergic Patients

Acronym

FluEMIST

Official Title

Flu Vaccine in Egg-allergic Patients Minimizing Injections Safety Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 1, 2011 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Walter Reed Army Medical Center

Collaborators

University of Texas, University of South Alabama, University of Michigan, Scripps Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Egg Allergy, Eligible for Vaccination Against Influenza

Keywords

egg allergy, influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FluMist (LAIV) group

Arm Type

Experimental

Arm Description

FluMist influenza vaccine 0.2 mL intranasal vaccine once

Arm Title

Flu shot (TIV) group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

FluMist intranasal influenza vaccine

Intervention Description

FluMist intranasal vaccine 0.2 mL will be given 0.1 mL in each nostril per manufacturer's instructions.

Intervention Type

Biological

Intervention Name(s)

Intramuscular influenza injection ("flu shot")

Other Intervention Name(s)

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)

Intervention Description

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.

Primary Outcome Measure Information:

Title

To estimate the safety of LAIV in egg-allergic patients receiving the LAIV.

Time Frame

within 48 hours after vaccine administration

Secondary Outcome Measure Information:

Title

To estimate the safety of a single, full-strength dose of TIV in egg allergic patients.

Time Frame

Within 48 hours of vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility 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: 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 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Laubach, MD

Organizational Affiliation

Walter Reed Army Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Walter Reed Army Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20307

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.cdc.gov/flu/index.htm

Description

CDC Information on Seasonal Influenza

URL

http://www.foodallergy.org

Description

Food Allergy and Anaphylaxis Network

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FluMist in Egg Allergic Patients

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