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:
Collaborator:
Information provided by (Responsible Party):
National Center for Occupational Health and Infection Control
ClinicalTrials.gov Identifier:
NCT01673425
First received: August 21, 2012
Last updated: September 2, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Influenza
Drug: Live Attenuated Influenza Vaccine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluating Immune Response to Seasonal FluMist in Healthy Adults

Resource links provided by NLM:


Further study details as provided by National Center for Occupational Health and Infection Control:

Primary Outcome Measures:
  • IgA Antibody Titers [ Time Frame: Change from baseline in antibody titer at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Antibody Response to LAIV [ Time Frame: Change from baseline in serum antibody response at 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: FluMist

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.
  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673425

Locations
United States, Florida
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
National Center for Occupational Health and Infection Control
Investigators
Principal Investigator: Lewis J. Radonovich, MD National Center for Occupational Health and Infection Control
  More Information

No publications provided

Responsible Party: National Center for Occupational Health and Infection Control
ClinicalTrials.gov Identifier: NCT01673425     History of Changes
Other Study ID Numbers: IRB 604-2010
Study First Received: August 21, 2012
Results First Received: July 29, 2014
Last Updated: September 2, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by National Center for Occupational Health and Infection Control:
Influenza
Influenza Vaccines
Vaccines, Attenuated
Immunity, Mucosal

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014