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Effects of Tobacco Products on Live Attenuated Influenza Virus (LAIV) Infections in Human Volunteers

NCT02019745 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2018-04-04

No results posted yet for this study

Summary

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.

Conditions

  • Influenza, Human
  • Smoking
  • Respiratory Tract Infections
  • Habits

Interventions

BIOLOGICAL

LAIV

Standard dose of LAIV administered by a licensed health care providers.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Food and Drug Administration (FDA)

    collaborator FED

  • Tobacco Centers of Regulatory Science (TCORS

    collaborator UNKNOWN

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Ilona Jaspers, PhD · University of North Carolina-Chapel Hill, Dept of Pediatrics

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019745 on ClinicalTrials.gov