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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Shanna H Graves, AAS
- 電話番号：205-975-2845
- メール：shannagraves@uabmc.edu
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
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コンタクト：
- Shanna H Graves, AAS
- 電話番号：205-975-2845
- メール：shannagraves@uabmc.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Nasal Mucosal Immune Response Following FluMist Vaccination
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Kevin S Harrod, PhD、UAB All Study (Central)
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-300016968
- UAB (その他の識別子：Anesthesiology)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
FluMist (Live Attenuated Influenza Vaccine)の臨床試験
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Serum Institute of India Pvt. Ltd.PATH完了
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GlaxoSmithKline完了