InfluenzaPhase 1NCT02597647
Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection
A Phase 1 study testing LAIV and Saline in people with Influenza, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- LAIV and Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Immunosuppressive conditions or medications
- chronic systemic medical illness
- infections or antibiotic use within the past 60 days
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- LAIV, Saline
- Keywords
- immunology, Microbiota
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAIVBiological
Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of LAIV.
SalineOther
Also called Ocean spray
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Changes from baseline at 1-2 weeks after LAIV or saline spray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- J. Craig Venter Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597647
- Sponsor's protocol ID
- IRB#11-000326-CR-00003
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2015
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26667497
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection
- ClinicalTrials.gov ID
- NCT02597647
- Acronym / sponsor ID
- IRB#11-000326-CR-00003
- Conditions
- Influenza
- Keywords
- immunology, Microbiota
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- J. Craig Venter Institute
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live attenuated influenza vaccine | Experimental | Biological: LAIVHealthy 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 | Other: SalineHealthy 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Immunosuppressive conditions or medications
- chronic systemic medical illness
- infections or antibiotic use within the past 60 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAIVSubjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of LAIV. | Biological | Live attenuated influenza vaccine |
| SalineAlso: Ocean spraySubjects 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 | Saline nasal spray |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 26667497Tarabichi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LAIV and Saline in people with Influenza, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.