Woodsmoke Exposure, Influenza Infection, and Nasal Immunity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Normal lung function,
oxygen saturation of >94%,
normal blood pressure,
no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing,
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LAIV nasal vaccine is chosen as a model viral infection
Biological/VaccineInoculation with LAIV
Wood smoke
Other interventionWood smoke exposure concentrations at 500 ug/m3 for two hours.
Placebo for LAIV nasal vaccine is chosen as a model viral infection
Biological/VaccinePlacebo for LAIV inoculation. Nasal administration of normal saline.
Placebo for Wood Smoke (clean Air Exposure)
Other interventionClean Air Exposure for 2 hours
Treatment groups
112 Participants
are divided into 4 treatment groupsGroup A: Wood smoke followed by LAIVExperimental treatment 2 interventions
Group B: Wood smoke followed by PlaceboActive comparator 2 interventions
Group C: Clean Air followed by LAIVActive comparator 2 interventions
Group D: Clean Air followed by PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Nasal Mucosal secretome (AUC)
Analysis of the nasal mucosal secretome (secreted factors identified as responsive to WS and/or LAIV). Area under the curve (AUC) will be calculated for each proteomic profile. Descriptive statistics (means and standard deviations) will be computed for outcomes of interest (AUCs), assuming normal distribution as in previous studies.
Time frame
Day 0 to Day 72
Gene Expression (AUC)
Tissue-level gene expression (genes identified as responsive to WS and/or LAIV) and assessed for: tissue-level gene expression and untargeted metabolomic and proteomic profiles. Area under the curve (AUC) will be calculated for each gene profile. Descriptive statistics (means and standard deviations) will be computed for outcomes of interest (AUCs), assuming normal distribution as in previous studies.
Time frame
Day 0 to Day 73
Virus Quantity (AUC)
Virus quantity in nasal secretions
Time frame
Day 0 to Day 74
Nasal Neutrophils (AUC)
nasal secretion
Time frame
Day 0 to Day 7Secondary outcomes
1
Peak Tissue gene expression
Peak value of Tissue-level gene expression (genes identified as responsive to WS and/or LAIV)
Time frame
Day 0 to Day 212
Peak nasal secretome
Peak Analysis value of the nasal mucosal secretome (secreted factors identified as responsive to WS and/or LAIV)
Time frame
Day 0 to Day 213
Peak Nasal Virus quantity
Peak value of Virus quantity in nasal secretions
Time frame
Day 0 to day 214
Peak nasal neutrophils
Peak value of nasal neutrophils
Time frame
Day 0 to Day 21Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Environmental Health Sciences (NIEHS)
Collaborator
Source ClinicalTrials.gov