FluMist in Egg Allergic Patients
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Influenza, Vaccines, Neurology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Otolaryngology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/5/2018 |
| Start Date: | September 2010 |
| End Date: | October 2012 |
Flu Vaccine in Egg-allergic Patients Minimizing Injections Safety Trial
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.
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.
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).
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).
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.
We found this trial at
1
site
6900 Georgia Ave NW
Washington, District of Columbia 20307
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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