Evaluating Immune Response to Seasonal FluMist in Healthy Adults

Influenza Clinical Trial

Official title:

Evaluating Immune Response to Seasonal FluMist in Healthy Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01673425
• Other study ID #: IRB 604-2010
• Status: Terminated
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: National Center for Occupational Health and Infection Control
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 49 Years

Eligibility

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).

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Live Attenuated Influenza Vaccine
All participants will be given FluMist.

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Occupational Health and Infection Control	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgA Antibody Titers		Change from baseline in antibody titer at 6 weeks
Secondary	Serum Antibody Response to LAIV		Change from baseline in serum antibody response at 6 weeks