RecruitingPhase 4NCT06841913

Woodsmoke Exposure, Influenza Infection, and Nasal Immunity

The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers


Sponsor

University of North Carolina, Chapel Hill

Enrollment

112 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 49 Years

Inclusion Criteria5

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

Exclusion Criteria10

  • 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

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Interventions

BIOLOGICALLAIV nasal vaccine is chosen as a model viral infection

Inoculation with LAIV

OTHERWood smoke

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

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

Placebo for LAIV inoculation. Nasal administration of normal saline.

OTHERPlacebo for Wood Smoke (clean Air Exposure)

Clean Air Exposure for 2 hours


Locations(1)

Mary Ellen Jones

Chapel Hill, North Carolina, United States

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NCT06841913


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