Official Title

Evaluating Immune Response to Seasonal FluMist in Healthy Adults
  • Phase

    N/A
  • Study Type

    Interventional
  • Study Participants

    5
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

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 Started
Sep 30
2012
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Results Posted
Sep 04
2014
Estimate
Last Update
Jan 27
2021

Drug Live Attenuated Influenza Vaccine

All participants will be given FluMist.

  • Other names: FluMist

Live Attenuated Influenza Vaccine Experimental

Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.

Criteria

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).

Summary

Study Enrollment

All Events

Event Type Organ System Event Term

IgA Antibody Titers

Experimental: Live Attenuated Influenza Vaccine

Serum Antibody Response to LAIV

Outcome Measure Data Not Reported

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Experimental: Live Attenuated Influenza Vaccine