How Healthy Adults Respond to the Nasal Flu Vaccine (MOSAIC)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Shanna H Graves, AAS
- Telefonní číslo: 205-975-2845
- E-mail: shannagraves@uabmc.edu
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama at Birmingham
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Kontakt:
- Shanna H Graves, AAS
- Telefonní číslo: 205-975-2845
- E-mail: shannagraves@uabmc.edu
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Nasal Mucosal Immune Response Following FluMist Vaccination
Časové okno: Baseline through 4 days post-vaccination
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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.
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Baseline through 4 days post-vaccination
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Kevin S Harrod, PhD, UAB All Study (Central)
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB-300016968
- UAB (Jiný identifikátor: Anesthesiology)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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