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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL149944 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Other | FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumist Quadrivalent Nasal Product | Drug | FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer |
|
| Measure | Description | Time Frame |
|---|---|---|
| influenza virus replication | virus replication will be measured using RT-PCR and reported as genomic units, from samples obtained from nasal washing and nasal oropharyngeal swabs | day 2 |
| markers of inflammation | a standard panel of inflammatory cytokines (Luminex Performance Human XL Cytokine Discovery Panel assay, R&D Systems; results reported in pg/ml) will be measured in samples obtained from nasal washing and nasal oropharyngeal swabs | change in inflammatory cytokines from baseline to day 2 |
| cystic fibrosis transmembrane conductance regulator function | nasal potential difference (NPD) measurement | change in NPD from baseline to day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Lung Health Center | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40720746 | Derived | Earnhardt EY, Tipper JL, Hanafy MA, Lazrak A, Lopez A, Perritt SE, LaFon DC, Mobley JA, Solomon GM, Harrod KS. Endoplasmic Reticulum Stress Disrupts the Airway Epithelium and Reduces Host Defense during Influenza A Virus Infection. Am J Respir Cell Mol Biol. 2026 Jan 1;74(1):40-51. doi: 10.1165/rcmb.2025-0141OC. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |