Effects of Tobacco Products on Live Attenuated Influenza Virus (LAIV) Infections in Human Volunteers
Completed
Conditions studied: Influenza, Human, Smoking, Respiratory Tract Infections, Habits
In brief
Chronic exposure to (cigarette smoke) CS causes biological changes, including airway remodeling and changes in baseline gene expression profiles at the level of the epithelium. Our own data indicate that chronic exposure to CS suppresses the ability of epithelial cells to enhance antiviral gene expression in response to influenza infection and activate host defense responses. While there is a large body of evidence supporting the notion that exposure to CS causes significant changes in host defense responses, which may be linked to permanent changes in epithelial cells at the genomic level, it is not known whether new and emerging tobacco products have similar or distinct effects. Using live attenuated influenza virus (LAIV) inoculation in human volunteers, this study will compare influenza-induced responses in non-smokers (NS), cigarette smokers (CS), e-cigarette smokers (EC), hookah smokers (HS), and Little Cigar smokers (LCS) in vivo. This will be done by analyzing nasal viral titers, antiviral defense responses, inflammatory mediator production, and markers of immune responses for LAIV-induced responses between the different groups of volunteers.
Key facts
- Study ID
- NCT02019745
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 62
- Starts
- 2014-06-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2018-04-04
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy, young nonsmoking adults age 18-45 years who are not routinely exposed to environmental tobacco smoke
- Healthy, young adults age 18-45 years who are active regular smokers (will be stratified based on cigarette, hookah, and Little Cigars)
You may not qualify if…
- Pregnancy or nursing;
- history of egg allergy;
- history of allergic rhinitis;
- aspirin therapy;
- asthma;
- immunodeficiency (HIV or other);
- on immunosuppressive drugs including corticosteroids;
- history of Guillain-Barre Syndrome;
- smokers with a forced expiratory volume in 1 second (FEV1) less than 75% predicted at screen;
- Chronic obstructive pulmonary disorder (COPD), cardiac disease, or any chronic cardiorespiratory condition;
- febrile and/or respiratory illness within past 3 weeks prior to entry into study
Where it is running
- Center for Environmental Medicine, Asthma and Lung Biology — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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