Recruiting

Woodsmoke

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06841913

Conditions

Smoke Exposure

Influenza

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

LAIV nasal vaccine is chosen as a model viral infection

Wood smoke

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

Placebo for Wood Smoke (clean Air Exposure)

Study Details

Brief 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.

Conditions

Smoke Exposure

Influenza

Study ID

NCT06841913

Start date

Sep 26, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Wood smoke followed by LAIV

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

active comparator: Wood smoke followed by Placebo

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

active comparator: Clean Air followed by LAIV

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

placebo comparator: Clean Air followed by Placebo

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

Interventions

LAIV nasal vaccine is chosen as a model viral infection

Inoculation with LAIV

Wood smoke

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

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

Placebo for LAIV inoculation. Nasal administration of normal saline.

Placebo for Wood Smoke (clean Air Exposure)

Clean Air Exposure for 2 hours

Primary outcome measure

  • Nasal Mucosal secretome (AUC) [ Time Frame: Day 0 to Day 7 ]
  • Gene Expression (AUC) [ Time Frame: Day 0 to Day 7 ]
  • Virus Quantity (AUC) [ Time Frame: Day 0 to Day 7 ]
  • Nasal Neutrophils (AUC) [ Time Frame: Day 0 to Day 7 ]
  • Nasal Viral Antibodies (AUC) [ Time Frame: Day 0 to Day 7 ]
  • Blood Viral Antibodies (AUC) [ Time Frame: Day 0 to Day 7 ]

Central Contacts and Locations

Central contacts

Carole Robinette, MS

919 966-5638carole_robinette@med.unc.edu

Chris Brooks

chris_brooks@med.unc.edu

Locations

Mary Ellen Jones

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • LAIV
  • Flumist
  • Influenza
  • Wood Smoke
  • Smoke
  • Fire

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-30.