Evaluating Immune Response to Seasonal FluMist in Healthy Adults
|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 ]
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|