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| Name | Class |
|---|---|
| J. Craig Venter Institute | OTHER |
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This study will serve to determine how influenza infection alters the bacterial colonization patterns in the nasal and oropharyngeal compartments, and whether the immune response correlate with these alterations. The investigators will be determining bacterial composition and immune responses in the nose and oropharynx during influenza infection.
Specific Aims
Therefore, the overall aims of this study are as follows:
Randomization and Post-Randomization Visits After undergoing the nasal swabs and nasopharyngeal washes, and nasal epithelial brushing, healthy volunteers will be randomly assigned to receive either saline nasal spray (placebo) or FluMist® nasal influenza vaccine (live attenuated influenza vaccine, or LAIV). They will return 1-2 weeks and 4-6 weeks later to repeat the nasal swabs and nasopharyngeal washes, and nasal epithelial brushings done at the Enrollment Visit.
Samples will be processed to isolate 16s bacterial RNA and host RNA. 16s rRNA will be analyzed by 16S sequencing for to determine the composition of the bacterial microbiome pre and post LAIV or saline (placebo) administration. Host immune responses will be assessed based upon microarray analysis of host RNA pre and post LAIV or saline administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live attenuated influenza vaccine | Experimental | Healthy adult volunteers given intranasal FluMist (Live Attenuated Influenza vaccine). Subjects will undergo nasal swabs, nasopharyngeal washes, and nasal epithelial brushings at baseline, 1-2 weeks, and 4-6 weeks after LAIV. |
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| Saline nasal spray | Placebo Comparator | Healthy adult volunteers given intranasal saline nasal spray. Subjects will undergo nasal swabs, nasopharyngeal washes, and nasal epithelial brushings at baseline, 1-2 weeks, and 4-6 weeks after saline administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAIV | Biological | Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of LAIV. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the bacterial composition (Bacterial "microbiome") over time | isolation of 16S RNA from nasal swabs and nasopharyngeal washes for 16S sequencing for bacterial microbiome | Changes from baseline at 1-2 weeks and 4-6 weeks after LAIV or saline spray |
| Changes in gene expression in the nasal lining of study participants | RNA isolation from nasal brushes which will undergo microarray analysis to measure changes in immune gene expression | Changes from baseline at 1-2 weeks after LAIV or saline spray |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26667497 | Derived | Tarabichi Y, Li K, Hu S, Nguyen C, Wang X, Elashoff D, Saira K, Frank B, Bihan M, Ghedin E, Methe BA, Deng JC. The administration of intranasal live attenuated influenza vaccine induces changes in the nasal microbiota and nasal epithelium gene expression profiles. Microbiome. 2015 Dec 15;3:74. doi: 10.1186/s40168-015-0133-2. |
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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 |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Other | Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of saline nasal spray. |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D017670 |
| Sodium Compounds |