How Healthy Adults Respond to the Nasal Flu Vaccine

NCT07726862 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: IRB-300016968UAB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucosal Immune Response to Influenza Vaccination

Keywords

FluMist, LAIV, influenza vaccine, mucosal immunity, nasal immune response, intranasal vaccine, healthy volunteers, nasal swab, proteomics

Outcome Measures

Primary Outcomes (1)

• Change in Nasal Mucosal Immune Response Following FluMist 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.

  Baseline through 4 days post-vaccination

Study Arms (1)

Healthy Adults Receiving Intranasal FluMist Vaccination

EXPERIMENTAL

Participants in this single-arm study will receive the FDA-approved live attenuated influenza vaccine (FluMist) administered intranasally according to standard dosing guidelines. All participants will undergo nasal sampling procedures, including nasal swabs and nasal wash, at baseline prior to vaccination and at approximately 2 and 4 days following vaccination. Samples will be collected to evaluate temporal changes in mucosal immune and epithelial responses using molecular and proteomic analyses. No placebo or comparator intervention is used.

Biological: FluMist (Live Attenuated Influenza Vaccine)

Interventions

FluMist (Live Attenuated Influenza Vaccine) BIOLOGICAL

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.

Healthy Adults Receiving Intranasal FluMist Vaccination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Kevin S Harrod, PhD

  UAB All Study (Central)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanna H Graves, AAS

CONTACT

205-975-2845; shannagraves@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research Director, Division of Molecular and Translational Biomedicine Benjamin Monroe Carraway Endowed Chair and Professor Department of Anesthesiology and Perioperative Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: July 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)