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Recruiting NCT06841913

Woodsmoke Exposure, Influenza Infection, and Nasal Immunity

Phase IV Interventional Smoke Exposure Influenza

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Smoke Exposure, Influenza. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Peak Tissue gene expression [Time frame: Day 0 to Day 21]
  • Peak nasal secretome [Time frame: Day 0 to Day 21]
  • Peak Nasal Virus quantity [Time frame: Day 0 to day 21]
  • Peak nasal neutrophils [Time frame: Day 0 to Day 21]
  • Peak Nasal virus anti-bodies [Time frame: Day 0 to Day 21]
  • Peak blood virus anti-bodies [Time frame: Day 0 to Day 21]
  • Peak Day of Tissue Gene Expression [Time frame: Day 0 to Day 21]
  • Peak Day of nasal secretome [Time frame: Day 0 to Day 21]
  • Peak Day of Nasal Virus quantity [Time frame: Day 0 to day 21]
  • Peak Day of nasal neutrophils [Time frame: Day 0 to Day 21]
  • Peak Day of Nasal virus anti-bodies [Time frame: Day 0 to Day 21]
  • Peak Day of blood virus anti-bodies [Time frame: Day 0 to Day 21]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Mary Ellen Jones — Chapel Hill

Identifiers

NCT: NCT06841913 · 24-1802 · 1R01ES036209-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗