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

21 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

20

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • University of Alabama at Birmingham
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Nasal Mucosal Immune Response Following FluMist Vaccination
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Alabama at Birmingham

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

30 juni 2030

Avslutad studie (Beräknad)

30 juni 2031

Studieregistreringsdatum

Först inskickad

21 juli 2026

Först inskickad som uppfyllde QC-kriterierna

21 juli 2026

Första postat (Faktisk)

24 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB-300016968
  • UAB (Annan identifierare: UAB)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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