Evaluating Immune Response to Seasonal FluMist in Healthy Adults
|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: NCT01673425|
Recruitment Status : Terminated (Low accrual(4 completed subjects over 2 months)& inconclusive nasal wash assays.)
First Posted : August 28, 2012
Results First Posted : September 4, 2014
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: Live Attenuated Influenza Vaccine||Not Applicable|
This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old.
- The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV.
- The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluating Immune Response to Seasonal FluMist in Healthy Adults|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Live Attenuated Influenza Vaccine
Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.
Drug: Live Attenuated Influenza Vaccine
All participants will be given FluMist.
Other Name: FluMist
- IgA Antibody Titers [ Time Frame: Change from baseline in antibody titer at 6 weeks ]
- Serum Antibody Response to LAIV [ Time Frame: Change from baseline in serum antibody response at 6 weeks ]
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): NCT01673425
|United States, Florida|
|Malcom Randall VA Medical Center|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Lewis J. Radonovich, MD||National Center for Occupational Health and Infection Control|