Evaluating Immune Response to Seasonal FluMist in Healthy Adults

January 25, 2021 updated by: National Center for Occupational Health and Infection Control
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • FluMist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IgA Antibody Titers
Time Frame: Change from baseline in antibody titer at 6 weeks
Change from baseline in antibody titer at 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Antibody Response to LAIV
Time Frame: Change from baseline in serum antibody response at 6 weeks
Change from baseline in serum antibody response at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Occupational Health and Infection Control

Collaborators

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Lewis J. Radonovich, MD, National Center for Occupational Health and Infection Control

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 28, 2012

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 604-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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