Mucosal Immune Response to Influenza Vaccination
Conditions
Keywords
FluMist, LAIV, influenza vaccine, mucosal immunity, nasal immune response, intranasal vaccine, healthy volunteers, nasal swab, proteomics
Brief summary
This study is looking at how the immune system in the nose responds after receiving the FluMist nasal flu vaccine in healthy adults. FluMist is an FDA-approved influenza vaccine that is given as a nasal spray. Healthy volunteers aged 18 to 65 who do not have chronic medical conditions, do not smoke, and have not recently received a flu vaccine will be enrolled. Participants will have three study visits over approximately one week. At the first visit, participants will be screened, give informed consent, and receive the FluMist vaccine. Nasal swabs and a gentle saline nasal wash will be collected before vaccination and again at two and four days after vaccination. The samples collected will be used to study changes in immune cells, proteins, and viral activity in the nose using laboratory techniques such as gene expression and protein analysis. This information may help researchers better understand how flu vaccines work at the site where infection begins and may support the development of improved vaccines in the future. There is no direct medical benefit expected for participants. Participation is voluntary, and all study procedures will be performed by trained clinical staff.
Detailed description
This is a prospective interventional study evaluating mucosal immune and epithelial responses in healthy adults following administration of the FDA-approved live attenuated influenza vaccine (FluMist) given as an intranasal spray. Healthy volunteers aged 18 to 65 years who do not smoke and who meet eligibility criteria will be enrolled. Participants will complete three study visits over approximately one week. At the first visit, informed consent, screening, baseline nasal swabs and nasal wash will be performed, followed by administration of FluMist. Follow-up nasal samples and safety assessments will be collected at approximately 2 and 4 days after vaccination. Nasal samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess local immune, epithelial, and viral responses. Samples will be coded, stored under secure conditions, and retained for up to five years after study completion. The objective of the study is to characterize early mucosal immune responses to FluMist vaccination and improve understanding of influenza vaccine-induced immunity at the site of infection.
Interventions
BIOLOGICALFluMist (Live Attenuated Influenza Vaccine)
FluMist is an FDA-approved live attenuated influenza vaccine administered as a nasal spray. Participants will receive a single standard dose of FluMist intranasally, with half the dose administered into each nostril by trained study personnel according to manufacturer instructions. The vaccine is used in this study to evaluate local mucosal and immune responses in the nasal cavity.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
This is a single-arm, prospective interventional study in which all participants receive the same intervention (intranasal FluMist vaccination). Participants are followed longitudinally with repeated nasal sampling at baseline and at defined time points after vaccination (Day 2 and Day 4) to assess temporal changes in mucosal immune and epithelial responses. No control group or randomization is used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults aged 18 to 65 years * Non-smokers (no smoking or vaping within the past 6 months) * No chronic lung disease or significant chronic medical conditions * No current or recent (within 1 month) upper or lower respiratory infection * Able and willing to provide informed consent * Have not received the current seasonal influenza vaccine * Able to comply with study procedures and follow-up visits
Exclusion criteria
* Age under 18 or over 65 years * Pregnancy or breastfeeding * Prisoners * Non-English speaking individuals * Immunocompromised individuals (including HIV/AIDS, immunosuppressive therapy, chemotherapy, or primary immunodeficiency) * Chronic medical conditions including asthma, chronic lung, liver, kidney, neurologic, hematologic, metabolic, or significant cardiovascular disease (except isolated hypertension) * History of chronic sinusitis or significant nasal allergies requiring frequent or daily treatment * Acute moderate or severe illness at time of enrollment, with or without fever * Receipt of influenza vaccine during the current season or within the past 2 weeks * Receipt of another live vaccine within 4 weeks prior to enrollment or planned during study period * Use of influenza antiviral medications (e.g., oseltamivir, zanamivir) within 48 hours prior to vaccination or planned use within 14 days after vaccination * History of severe allergic reaction to influenza vaccine or any component of FluMist (including egg allergy if applicable) * History of Guillain-Barré syndrome following influenza vaccination * Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nasal Mucosal Immune Response Following FluMist Vaccination | Baseline through 4 days post-vaccination | This outcome measure evaluates changes in the nasal mucosal immune and epithelial response following administration of the intranasal live attenuated influenza vaccine (FluMist). Nasal swab and nasal wash samples will be collected at baseline (pre-vaccination) and at approximately 2 and 4 days post-vaccination. Samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess changes in immune cell populations, gene expression profiles, protein expression, and viral activity over time. |
Countries
United States
Contacts
CONTACTShanna H Graves, AAS
PRINCIPAL_INVESTIGATORKevin S Harrod, PhD
UAB All Study (Central)
Outcome results
None listed