Protection From Influenza: Determining the Impact of Prior Infection
調査の概要
詳細な説明
Significance: This study will provide critical information on the best technique in vaccine candidate testing and improve influenza treatment approaches. The long-term goal of this research is to identify the T-cell responses that are surrogates (biomarkers) of serious complications of influenza in older adults and predict vaccine efficacy (prevention of influenza illness) and vaccine effectiveness (prevention of serious complications). Further, translating new insights into age-related immune dysfunction to the design of new influenza vaccines is critical to addressing this unmet need in the population aged 65 and older.
Innovation: The study will help in the validation of clinical tools and biomarkers as prognostic indicators of influenza illness severity in vaccinated older adults, point-of-care diagnostics that would direct other preventive strategies to reduce the impact of influenza illness in vaccinated older adults, and correlates of protection to evaluate the potential of new influenza vaccines to enhance protection against the serious complications of influenza illness. The investigators have established that GrzB activity and the IFNg: IL-10 ratio in influenza-stimulated PBMC correlate with protection against influenza, and preliminary data to show that low GrzB activity in influenza-stimulated PBMC correlates with more severe disease and higher levels of frailty. The innovations of this project are the established methods for developing correlates of protection, the clinical insights into how frailty affects immune-mediated protection against influenza, and the direct translation of this research to provide a reasonable method for primary care clinicians to estimate vaccine effectiveness in an individual older person. These results will translate to the practical design of clinical trials to evaluate the potential for new influenza vaccines to better protect against the serious complications of influenza and complement those based on antibody titers and/or clinical outcomes alone.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Amanda Axler, BSc.
- 電話番号：1924 7055237300
- メール：aaxler@hsnri.ca
研究場所
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-
Ontario
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Sudbury、Ontario、カナダ、P3E 5J1
- 募集
- Health Sciences North Research Institute
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コンタクト：
- Amanda l Axler, BSc
- 電話番号：1924 705-523-7300
- メール：aaxler@amric.ca
-
コンタクト：
- Beth Gentleman, BSc
- 電話番号：2631 705-523-7300
- メール：bgentleman@amric.ca
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主任研究者：
- Janet E McElhaney, MD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Written informed consent provided by the participant.
Age 65 years of age or older admitted to Health Sciences North with at least one the following:
- Laboratory confirmed influenza illness
- Acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
- Any respiratory or influenza-like symptoms (dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness) that a test for influenza was negative.
- Willing to receive influenza vaccination in the subsequent flu season
Exclusion Criteria:
- Patients whose reason for hospital admission was unrelated to influenza or (for example patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory).
- Chest x-ray positive for pneumonia.
- Study participants who cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination.
- Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily).
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Case
older adult patients (over the age of 65) admitted to Health Sciences North with laboratory confirmed influenza illness (LCII)
|
|
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Control
matched control subjects (non-LCII)
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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 |
|---|---|---|
|
High expression of CTL associated cytokines and granzymes in PBMC's are predictors of influenza infection severity.
時間枠：2 years
|
PBMCs from adults hospitalized for laboratory confirmed influenza illness (LCII) will be collected at admission and 30 days post hospitalization.
These samples will be matched with hospitalized non-LCII adult controls.
T-cells will be isolated from whole blood samples and gene expression of IFNg, IL10 and GrzB will be measured and compared between time points and subjects.
These levels do not have a separate unit of measure.
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Vaccination in previously infected individuals increases the protection provided by subsequent vaccination and will be higher than those receiving vaccination alone (with no previous infection)
時間枠：2 years
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Older adults hospitalized for influenza illness the previous season will be compared to matched, hospitalized older adults with influenza-like illness (non-LCII).
PBMCs will be collected from each group, before receiving influenza vaccination and 4 weeks after vaccination.
PBMCs will be challenged ex vivo with influenza virus and gene expression of CTL related genes will be measured and compared between each group.
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2 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
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
- Protection from Influenza
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?
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。
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