Woodsmoke Exposure, Influenza Infection, and Nasal Immunity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-10-01

Study Completion Date

2028-12-31

Brief Summary

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This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production.

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Detailed Description

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This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases LAIV-induced nasal symptoms, and reduces mucosal antibody production. Healthy volunteers will be randomized for a 2-hr exposure to WS or placebo (filtered air) and then inoculated with either live attenuated influenza virus (LAIV) or placebo. Nasal mucosal samples, symptoms, and peripheral blood will be collected on days 1,2,3,7, and 21 post-exposure/LAIV and assessed for a) mucosal antiviral responses using targeted and non-targeted analysis of the secretome and tissue-level gene expression; b) symptoms, virus quantity, differential cell count, and virus-specific antibody levels; and c) biomarker signatures associated with infection outcomes using computational modeling tools.

Conditions

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Smoke Exposure Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

25% of participants (N=100 total for the study) will undergo each of the following.

Wood smoke followed by LAIV (N=25) Wood smoke followed by Placebo (N=25) Clean Air followed by LAIV (N=25) Clean Air followed by Placebo (N=25)

Males and females will be equally enrolled into each of the above cohorts.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This is a randomized, double-blinded study so packaging and labeling by IDS is such that both study participants and study personnel (lab techs) will be blinded to the treatment (either LAIV or placebo) given. Due to the smell of the WS it will not be possible to completely blind subjects or coordinators as to exposure. The contractor maintaining the woodsmoke exposure chamber add a small amount of woodsmoke into the chamber to minimize bias. The risk for bias is felt to be minimal because all of the study's primary and most of the secondary outcomes are laboratory assays for which the technicians performing the assays will be blinded as to subject group. Unblinding will occur at the conclusion of the study or earlier if needed for safety purposes and as dictated by the UNC IRB, study sponsor, and DSMB.

Study Groups

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Wood smoke followed by LAIV

Participants will receive LAIV after a 2 hour wood smoke exposure.

Group Type EXPERIMENTAL

LAIV nasal vaccine is chosen as a model viral infection

Intervention Type BIOLOGICAL

Inoculation with LAIV

Wood smoke

Intervention Type OTHER

Wood smoke exposure concentrations at 500 ug/m3 for two hours.

Wood smoke followed by Placebo

Participants will receive a LAIV placebo after a 2 hour wood smoke exposure.

Group Type ACTIVE_COMPARATOR

Wood smoke

Intervention Type OTHER

Wood smoke exposure concentrations at 500 ug/m3 for two hours.

Placebo for LAIV nasal vaccine is chosen as a model viral infection

Intervention Type BIOLOGICAL

Placebo for LAIV inoculation. Nasal administration of normal saline.

Clean Air followed by LAIV

Participants will receive LAIV after a 2 hour clean air exposure.

Group Type ACTIVE_COMPARATOR

LAIV nasal vaccine is chosen as a model viral infection

Intervention Type BIOLOGICAL

Inoculation with LAIV

Placebo for Wood Smoke (clean Air Exposure)

Intervention Type OTHER

Clean Air Exposure for 2 hours

Clean Air followed by Placebo

Participants will receive a LAIV placebo after a 2 hour clean air exposure.

Group Type PLACEBO_COMPARATOR

Placebo for LAIV nasal vaccine is chosen as a model viral infection

Intervention Type BIOLOGICAL

Placebo for LAIV inoculation. Nasal administration of normal saline.

Placebo for Wood Smoke (clean Air Exposure)

Intervention Type OTHER

Clean Air Exposure for 2 hours

Interventions

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LAIV nasal vaccine is chosen as a model viral infection

Inoculation with LAIV

Intervention Type BIOLOGICAL

Wood smoke

Wood smoke exposure concentrations at 500 ug/m3 for two hours.

Intervention Type OTHER

Placebo for LAIV nasal vaccine is chosen as a model viral infection

Placebo for LAIV inoculation. Nasal administration of normal saline.

Intervention Type BIOLOGICAL

Placebo for Wood Smoke (clean Air Exposure)

Clean Air Exposure for 2 hours

Intervention Type OTHER

Other Intervention Names

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Live Attenuated Influenza Vaccine Flumist

Eligibility Criteria

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Inclusion Criteria

* Normal lung function,
* oxygen saturation of \>94%,
* normal blood pressure,
* no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing,
* 18-49 Years of age.

Exclusion Criteria

* A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
* Positive pregnancy test within 48 hours of the time of challenge
* Use of any inhaled substance (for medical or recreational purposes).
* Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year.
* History of allergy to eggs
* Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks
* Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.
* Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation.
* Use of immunosuppressive drugs within the past 6 months.
* Previous Woodsmoke exposure \<3 weeks, which is considered to an appropriate washout period

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes