Wood smoke and nasal immune response to the flu

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy volunteers are randomized to a two-hour exposure to either wood smoke or filtered air, then receive either live attenuated influenza vaccine (LAIV) or placebo. Nasal samples, symptom reports, and blood are collected on days 1, 2, 3, 7, and 21 to measure viral quantity, mucosal secreted proteins, tissue-level gene expression, cell counts, and virus-specific antibodies. Targeted and untargeted analyses of the nasal secretome and gene expression are used alongside computational modeling to identify biomarker signatures associated with infection outcomes. The approach tests whether wood smoke alters mucosal antiviral defenses and increases LAIV-induced nasal symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Mary Ellen Jones
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Meghan Rebuli, PhD — UNC
• Study coordinator: Carole Robinette, MS
• Email: carole_robinette@med.unc.edu
• Phone: 919 966-5638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.