Evaluating Immune Response to Seasonal FluMist in Healthy Adults

Not Applicable

Terminated

• Conditions: Influenza
• Interventions: Drug: Live Attenuated Influenza Vaccine

• Registration Number: NCT01673425
• Lead Sponsor: National Center for Occupational Health and Infection Control

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Study Start: 2012-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-07-29
• Status Verified: 2014-08
• Results First Submitted QC: 2014-09-02
• Results First Posted: 2014-09-04
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Live Attenuated Influenza Vaccine	Live Attenuated Influenza Vaccine	Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.

Primary Outcome Measures

Name	Time	Method
IgA Antibody Titers	Change from baseline in antibody titer at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Serum Antibody Response to LAIV	Change from baseline in serum antibody response at 6 weeks

Trial Locations

Locations (1)

Malcom Randall VA Medical Center; 🇺🇸 Gainesville, Florida, United States