Influenza
Conditions
Keywords
Influenza, Influenza Vaccines, Vaccines, Attenuated, Immunity, Mucosal
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 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.
Interventions
All participants will be given FluMist.
Sponsors
US Department of Veterans Affairs
National Center for Occupational Health and Infection Control
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IgA Antibody Titers | Change from baseline in antibody titer at 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum Antibody Response to LAIV | Change from baseline in serum antibody response at 6 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Live Attenuated Influenza Vaccine Study This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Live Attenuated Influenza Vaccine Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
IgA Antibody Titers
Time frame: Change from baseline in antibody titer at 6 weeks
Population: This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.
Secondary
Serum Antibody Response to LAIV
Time frame: Change from baseline in serum antibody response at 6 weeks