Trial | NCT02597647  Report issue

Official Title

Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    17
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:

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;
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.
Study Started
Feb 28
2011
Primary Completion
Apr 30
2014
Study Completion
Apr 30
2014
Last Update
Jul 06
2016
Estimate

Biological LAIV

Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of LAIV.

Other Saline

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.

  • Other names: Ocean spray

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.

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.

Criteria 

Inclusion Criteria:

Healthy volunteers:
Healthy subjects between the ages of 18 and 65. Approximately half of the subjects will be female and approximately half will be male.
Must be eligible to receive live-attenuated nasal version of the influenza vaccine.
Must be able to provide signed and dated informed consent.
Healthy subjects willing and able to provide oropharyngeal and nasal cavity specimens

Exclusion Criteria:

Immunosuppressive conditions or medications
chronic systemic medical illness
infections or antibiotic use within the past 60 days
No Results Posted