Woodsmoke Exposure, Influenza Infection, and Nasal Immunity

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06841913
Phase
PHASE4
Status
Recruiting
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Conditions

  • Influenza
  • Smoke Exposure

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • LAIV nasal vaccine is chosen as a model viral infection — BIOLOGICAL
    Inoculation with LAIV
  • Wood smoke — OTHER
    Wood smoke exposure concentrations at 500 ug/m3 for two hours.
  • Placebo for LAIV nasal vaccine is chosen as a model viral infection — BIOLOGICAL
    Placebo for LAIV inoculation. Nasal administration of normal saline.
  • Placebo for Wood Smoke (clean Air Exposure) — OTHER
    Clean Air Exposure for 2 hours

Study Details

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.

Key Dates

Start date
Sep 26, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Nasal Mucosal secretome (AUC) [ Time Frame: Day 0 to Day 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mary Ellen JonesChapel HillNorth Carolina27599-

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Mary Ellen Jones· Chapel Hill, NC

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