Influenza Clinical Trial
Official title:
Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection
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:
1. To identify baseline composition and kinetic changes in the nasal and oropharyngeal
microflora and immune responses after administering intranasal live attenuated
influenza virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;
2. To identify nasal and oropharyngeal microbial composition and local immune responses
during influenza infections and after resolution of infection, and correlate these
changes with clinical outcomes.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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