Egg AllergyPhase 1/2FluEMISTNCT01248208
FluMist in Egg Allergic Patients
A Phase 1/2 study testing FluMist intranasal influenza vaccine and Intramuscular influenza injection ("flu shot") in people with Egg Allergy and Eligible for Vaccination Against Influenza, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Egg Allergy, Eligible for Vaccination Against Influenza
- What is being tested?
- FluMist intranasal influenza vaccine and Intramuscular influenza injection ("flu shot")
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: 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.
Read the 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).
- Being tested
- FluMist intranasal influenza vaccine, Intramuscular influenza injection ("flu shot")
- Keywords
- egg allergy, influenza vaccine
- Medical subject headings
- Egg Hypersensitivity, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMist intranasal influenza vaccineBiological
FluMist intranasal vaccine 0.2 mL will be given 0.1 mL in each nostril per manufacturer's instructions.
Intramuscular influenza injection ("flu shot")Biological
Also called Fluzone (approved for children down to 6 months), Fluvirin (age 4y and older), Agriflu (age 18y and older), Fluarix (age 3y and older)
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.
| Study group | Role | What they receive |
|---|---|---|
| FluMist (LAIV) group | Experimental | FluMist influenza vaccine 0.2 mL intranasal vaccine once Receives: Biological: FluMist intranasal influenza vaccine |
| Flu shot (TIV) group | Active comparator | 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. Receives: Biological: Intramuscular influenza injection ("flu shot") |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the safety of LAIV in egg-allergic patients receiving the LAIV.
Measured: within 48 hours after vaccine administration
Secondary outcomes (1)
To estimate the safety of a single, full-strength dose of TIV in egg allergic patients.
Measured: Within 48 hours of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startSep 2010
- Primary completion1 Sep 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Egg AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Texas, University of South Alabama, University of Michigan, Scripps Clinic
- Responsible party
- Principal investigator, Susan Laubach, Walter Reed Army Medical Center
- Investigators
- Susan Laubach, MD, Study director, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248208
- Sponsor's protocol ID
- 357349
- Acronym
- FluEMIST
- Status last verified
- Oct 2018
- First submitted
- 24 Nov 2010
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flu Vaccine in Egg-allergic Patients Minimizing Injections Safety Trial
- ClinicalTrials.gov ID
- NCT01248208
- Acronym / sponsor ID
- FluEMIST / 357349
- Keywords
- egg allergy, influenza vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- University of Texas, University of South Alabama, University of Michigan, Scripps Clinic
- Study start
- Sep 2010
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FluMist (LAIV) group | Experimental | Biological: FluMist intranasal influenza vaccineFluMist influenza vaccine 0.2 mL intranasal vaccine once |
| Flu shot (TIV) group | Active comparator | Biological: Intramuscular influenza injection ("flu shot")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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluMist intranasal influenza vaccineFluMist intranasal vaccine 0.2 mL will be given 0.1 mL in each nostril per manufacturer's instructions. | Biological | FluMist (LAIV) group |
| Intramuscular influenza injection ("flu shot")Also: Fluzone (approved for children down to 6 months), Fluvirin (age 4y and older), Agriflu (age 18y and older), Fluarix (age 3y and older)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. | Biological | Flu shot (TIV) group |
Primary outcome
To estimate the safety of LAIV in egg-allergic patients receiving the LAIV.
Time frame: within 48 hours after vaccine administration
1 secondary outcome
To estimate the safety of a single, full-strength dose of TIV in egg allergic patients.
Time frame: Within 48 hours of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Food Allergy and Anaphylaxis NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Laubach, MD study director
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FluMist intranasal influenza vaccine and Intramuscular influenza injection ("flu shot") in people with Egg Allergy and Eligible for Vaccination Against Influenza, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the safety of LAIV in egg-allergic patients receiving the LAIV. (time frame: within 48 hours after vaccine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.