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How Healthy Adults Respond to the Nasal Flu Vaccine (MOSAIC)

21. juli 2026 opdateret af: Kevin Harrod, University of Alabama at Birmingham

Characterizing Local Mucosal Responses to Live Attenuated Influenza Vaccine in Healthy Adults

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: FluMist (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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Nasal Mucosal Immune Response Following FluMist Vaccination
Tidsramme: 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.
Baseline through 4 days post-vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alabama at Birmingham

Efterforskere

  • Ledende efterforsker: Kevin S Harrod, PhD, UAB All Study (Central)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

30. juni 2030

Studieafslutning (Anslået)

30. juni 2031

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-300016968
  • UAB (Anden identifikator: Anesthesiology)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared with other researchers. The study involves collection of sensitive health information and high-dimensional molecular data (including transcriptomic and proteomic analyses) linked to coded identifiers. To protect participant privacy and confidentiality, data will be stored in secure, HIPAA-compliant systems with access limited to IRB-approved study personnel. Only de-identified, aggregated results will be reported in publications and presentations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med FluMist (Live Attenuated Influenza Vaccine)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Egypt

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner