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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02597647
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
J. Craig Venter Institute
Information provided by (Responsible Party):
University of California, Los Angeles

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. 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.

Condition or disease Intervention/treatment Phase
Influenza Biological: LAIV Other: Saline Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection
Study Start Date : February 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Live attenuated influenza vaccine
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
Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of LAIV.

Placebo Comparator: Saline nasal spray
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
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 Name: Ocean spray




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597647


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
J. Craig Venter Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02597647    
Other Study ID Numbers: IRB#11-000326-CR-00003
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Keywords provided by University of California, Los Angeles:
immunology
Microbiota
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases