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Evaluating Immune Response to Seasonal FluMist in Healthy Adults

Primary Purpose

Influenza

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Live Attenuated Influenza Vaccine
Sponsored by
National Center for Occupational Health and Infection Control
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza focused on measuring Influenza, Influenza Vaccines, Vaccines, Attenuated, Immunity, Mucosal

Eligibility Criteria

20 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Malcom Randall VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Live Attenuated Influenza Vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

IgA Antibody Titers

Secondary Outcome Measures

Serum Antibody Response to LAIV

Full Information

First Posted
August 21, 2012
Last Updated
January 25, 2021
Sponsor
National Center for Occupational Health and Infection Control
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01673425
Brief Title
Evaluating Immune Response to Seasonal FluMist in Healthy Adults
Official Title
Evaluating Immune Response to Seasonal FluMist in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Low accrual(4 completed subjects over 2 months)& inconclusive nasal wash assays.
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Occupational Health and Infection Control
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Influenza Vaccines, Vaccines, Attenuated, Immunity, Mucosal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Attenuated Influenza Vaccine
Arm Type
Experimental
Arm Description
Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.
Intervention Type
Drug
Intervention Name(s)
Live Attenuated Influenza Vaccine
Other Intervention Name(s)
FluMist
Intervention Description
All participants will be given FluMist.
Primary Outcome Measure Information:
Title
IgA Antibody Titers
Time Frame
Change from baseline in antibody titer at 6 weeks
Secondary Outcome Measure Information:
Title
Serum Antibody Response to LAIV
Time Frame
Change from baseline in serum antibody response at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis J. Radonovich, MD
Organizational Affiliation
National Center for Occupational Health and Infection Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluating Immune Response to Seasonal FluMist in Healthy Adults

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