Not provided
Not provided
Not provided
Not provided
Not provided
Low accrual(4 completed subjects over 2 months)& inconclusive nasal wash assays.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Attenuated Influenza Vaccine | Experimental | Single intervention study- all participants will receive LAIV instead of injectable flu vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Attenuated Influenza Vaccine | Drug | All participants will be given FluMist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| IgA Antibody Titers | Change from baseline in antibody titer at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Antibody Response to LAIV | Change from baseline in serum antibody response at 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lewis J. Radonovich, MD | National Center for Occupational Health and Infection Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malcom Randall VA Medical Center | Gainesville | Florida | 32608 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Live Attenuated Influenza Vaccine | Single intervention study; all participants receive LAIV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Live Attenuated Influenza Vaccine Study | This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IgA Antibody Titers | This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples. | Posted | Change from baseline in antibody titer at 6 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Enrollment | Low accrual. Only 4 subjects completed study in 2 month period. Study terminated. |
Not provided
Not provided
This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lewis Radonovich | VA National Center for Occupational Health & Infection Control | 352-376-1611 | 4988 | Lewis.radonovich@va.gov |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C000613429 | FluMist |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Serum Antibody Response to LAIV | Not Posted | Change from baseline in serum antibody response at 6 weeks | Participants |
| 0 |
| 5 |
| 0 |
| 5 |
Not provided
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |