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Completed

NCT Number: NCT02597647

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Ocean spray

Primary outcomes

  1. Changes in the bacterial composition (Bacterial "microbiome") over time

    Time frame: Changes from baseline at 1-2 weeks and 4-6 weeks after LAIV or saline spray

    isolation of 16S RNA from nasal swabs and nasopharyngeal washes for 16S sequencing for bacterial microbiome

  2. Changes in gene expression in the nasal lining of study participants

    Time frame: Changes from baseline at 1-2 weeks after LAIV or saline spray

    RNA isolation from nasal brushes which will undergo microarray analysis to measure changes in immune gene expression

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • J. Craig Venter Institute

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2015
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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