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Evaluating Immune Response to Seasonal FluMist in Healthy Adults

This study has been terminated.
(Low accrual(4 completed subjects over 2 months)& inconclusive nasal wash assays.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673425
First Posted: August 28, 2012
Last Update Posted: September 4, 2014
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.
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
National Center for Occupational Health and Infection Control
August 21, 2012
August 28, 2012
July 29, 2014
September 4, 2014
September 4, 2014
September 2012
December 2012   (Final data collection date for primary outcome measure)
IgA Antibody Titers [ Time Frame: Change from baseline in antibody titer at 6 weeks ]
Same as current
Complete list of historical versions of study NCT01673425 on ClinicalTrials.gov Archive Site
Serum Antibody Response to LAIV [ Time Frame: Change from baseline in serum antibody response at 6 weeks ]
Same as current
Not Provided
Not Provided
 
Evaluating Immune Response to Seasonal FluMist in Healthy Adults
Evaluating Immune Response to Seasonal FluMist in Healthy Adults
The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.

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.

Specific Aims

  1. 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.
  2. The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Influenza
Drug: Live Attenuated Influenza Vaccine
All participants will be given FluMist.
Other Name: FluMist
Experimental: Live Attenuated Influenza Vaccine
Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.
Intervention: Drug: Live Attenuated Influenza Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Medically eligible healthy men and women between the ages of 20 to 49 years old.

Exclusion Criteria:

  • A medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system.
  • A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine
  • Currently pregnant
  • Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components
  • Have had flu within the current flu season.
  • Have had a flu vaccine within the current flu season.
  • Have close contact with someone whose immune system is so weak they require care in a protected environment (such as bone marrow transplant unit).
Sexes Eligible for Study: All
20 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01673425
IRB 604-2010
No
Not Provided
Not Provided
National Center for Occupational Health and Infection Control
National Center for Occupational Health and Infection Control
VA Office of Research and Development
Principal Investigator: Lewis J. Radonovich, MD National Center for Occupational Health and Infection Control
National Center for Occupational Health and Infection Control
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP