Not Yet RecruitingPhase 4

How Healthy Adults Respond to the Nasal Flu Vaccine

United States20 participantsStarted 2026-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Nasal Mucosal Immune Response Following FluMist Vaccination

Timeframe: Baseline through 4 days post-vaccination

Trial details

NCT IDNCT07726862

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06-30

Contact for this trial

Shanna H Graves, AAS

205-975-2845 shannagraves@uabmc.edu

View on ClinicalTrials.gov More Mucosal Immune Response to Influenza Vaccination trials