How Healthy Adults Respond to the Nasal Flu Vaccine | NCT07726862

NCT07726862

Overview

NCT ID: NCT07726862
Lead Sponsor: University of Alabama at BirminghamOTHER
Official Title: Characterizing Local Mucosal Responses to Live Attenuated Influenza Vaccine in Healthy Adults
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Jun 30, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 20Estimated
Primary Purpose: Basic Science
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Shanna H Graves, AASContact
shannagraves@uabmc.edu205-975-2845

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

Similar Studies