Using a nasal vaccine to model influenza infection
Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection
This study is testing a nasal vaccine for the flu in healthy adults to see how their immune system responds and to better understand the infection.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04164212 on ClinicalTrials.gov |
What this trial studies
This study aims to create a nasal model for influenza infection by administering the live attenuated influenza vaccine (LAIV) to healthy adult volunteers. Participants will provide nasal specimens to assess the presence of the influenza virus and measure inflammatory and immune responses. Additionally, a subset of participants will have their cystic fibrosis transmembrane conductance regulator (CFTR) function evaluated through nasal potential difference measurements. The study focuses on understanding the immune response to influenza in a controlled setting.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-49 who have not yet received the influenza vaccine for the 2019-2020 season.
Not a fit: Patients with immunocompromising conditions, chronic diseases, or recent respiratory infections are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of influenza infections and improve vaccine development.
How similar studies have performed: Other studies using similar nasal vaccine models have shown promise in understanding respiratory infections, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ages 18-49 years old, * not yet received influenza vaccine for 2019-2020, and * capable of giving signed informed consent. Exclusion Criteria: * Immunocompromising condition (e.g. HIV/AIDS, chemotherapy, immune suppressing medications), * active smoking within past 6 months, * asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure, * pregnancy, * current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids), * prior adverse reaction to influenza vaccine, * history of Guillain-Barre syndrome, * egg allergy, * close contact with an individual with severe immunodeficiency/immunosuppression.
Where this trial is running
Birmingham, Alabama
- UAB Lung Health Center — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: David LaFon, MD
- Email: dlafon@uabmc.edu
- Phone: 205-934-0266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.