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NCT06841913 | NOT YET RECRUITING | Smoke Exposure

Woodsmoke Exposure, Influenza Infection, and Nasal Immunity
Sponsor:

University of North Carolina, Chapel Hill

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.

Condition or disease

Smoke Exposure

Influenza

Intervention/treatment

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)

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 112 participants
Masking : DOUBLE
Masking Description : This is a randomized, double-blinded study so packaging and labeling by IDS is such that both study participants and study personnel (lab techs) will be blinded to the treatment (either LAIV or placebo) given. Due to the smell of the WS it will not be possible to completely blind subjects or coordinators as to exposure. The contractor maintaining the woodsmoke exposure chamber add a small amount of woodsmoke into the chamber to minimize bias. The risk for bias is felt to be minimal because all of the study's primary and most of the secondary outcomes are laboratory assays for which the technicians performing the assays will be blinded as to subject group. Unblinding will occur at the conclusion of the study or earlier if needed for safety purposes and as dictated by the UNC IRB, study sponsor, and DSMB.
Primary Purpose : BASIC_SCIENCE
Official Title : The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers
Actual Study Start Date : 2025-03-01
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 49 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Woodsmoke Exposure, Influenza Infection, and Nasal Immunity

Location Details

NCT06841913

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How to Participate

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Locations

Not yet recruiting

United States, North Carolina

Human Studies Facility

Chapel Hill, North Carolina, United States, 27599