Evaluating Immune Response to Seasonal FluMist in Healthy Adults

NCT01673425 | Terminated Results

• 1 other identifier: IRB 604-2010
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Influenza Vaccines; Vaccines, Attenuated; Immunity, Mucosal

Outcome Measures

Primary Outcomes (1)

• IgA Antibody Titers

  Change from baseline in antibody titer at 6 weeks

Secondary Outcomes (1)

• Serum Antibody Response to LAIV

  Change from baseline in serum antibody response at 6 weeks

Study Arms (1)

Live Attenuated Influenza Vaccine

EXPERIMENTAL

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

Drug: Live Attenuated Influenza Vaccine

Interventions

Live Attenuated Influenza Vaccine DRUG

All participants will be given FluMist.

Also known as: FluMist

Live Attenuated Influenza Vaccine

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Medically eligible healthy men and women between the ages of 20 to 49 years old.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Center for Occupational Health and Infection Control: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.

Results Point of Contact

• Title: Lewis Radonovich
• Organization: VA National Center for Occupational Health & Infection Control

Lewis.radonovich@va.gov

352-376-1611

Study Officials

• Lewis J. Radonovich, MD

  National Center for Occupational Health and Infection Control

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 28, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 27, 2021
• Results First Posted: September 4, 2014

Record last verified: 2014-08

Locations

US (1)