FluMist in Egg Allergic Patients (FluEMIST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01248208|
Recruitment Status : Unknown
Verified November 2010 by Walter Reed Army Medical Center.
Recruitment status was: Recruiting
First Posted : November 25, 2010
Last Update Posted : November 25, 2010
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 or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Flu Vaccine in Egg-allergic Patients Minimizing Injections Safety Trial|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2011|
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:
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.
- To estimate the safety of LAIV in egg-allergic patients receiving the LAIV. [ Time Frame: within 48 hours after vaccine administration ]
- To estimate the safety of a single, full-strength dose of TIV in egg allergic patients. [ Time Frame: Within 48 hours of vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248208
|Contact: Kristi McKinney, MDfirstname.lastname@example.org|
|Contact: Susan Laubach, MDemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Susan Laubach, MD 202-782-9471 email@example.com|
|Principal Investigator: Kristi McKinney, MD|
|Sub-Investigator: Susan Laubach, MD|
|Study Director:||Susan Laubach, MD||Walter Reed Army Medical Center|