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

NCT02597647 | Completed Phase 1

• 1 other identifier: IRB#11-000326-CR-00003
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Influenza

Keywords

immunology; Microbiota

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Biological: 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.

Other: Saline

Interventions

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.

Live attenuated influenza vaccine

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.

Also known as: Ocean spray

Saline nasal spray

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Immunosuppressive conditions or medications
• chronic systemic medical illness
• infections or antibiotic use within the past 60 days

Sponsors & Collaborators

• University of California, Los Angeles: lead
• J. Craig Venter Institute: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 26667497 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 5, 2015
• Study Start: February 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)