How Healthy Adults Respond to the Nasal Flu Vaccine

Conditions

• Mucosal Immune Response to Influenza Vaccination

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

First listed

Jul 24, 2026

Start date

Oct 1, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2031

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Healthy Adults Receiving Intranasal FluMist Vaccination
  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.

Primary Outcome Measure

Change in Nasal Mucosal Immune Response Following FluMist Vaccination [ Time Frame: Baseline through 4 days post-vaccination ]

Central Contacts

• Shanna H Graves, AAS
  205-975-2845
  [email protected]

Locations (1)

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