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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597647
• Other study ID #: IRB#11-000326-CR-00003
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2015
• Last updated: July 1, 2016
• Start date: February 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	J. Craig Venter Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No