Severe Asthma Covid Vaccine Response Study (SHINE)
SHINE: Severe Asthma Covid Vaccine Response Study
調査の概要
状態
詳細な説明
SARS-CoV-2 and the resulting COVID-19 pandemic has had a major impact on quality of life in people with severe asthma. Careful isolation and lockdown measures have protected many patients, but with major impacts on wellbeing and mental health. Vaccination opens a "light at the end of the tunnel" by protecting against COVID-19. However, the following questions remain unanswered for Covid vaccination in severe asthma: 1) What are patients' expectations/attitudes towards vaccination? 2) Will vaccines induce good immune responses which protect from Covid-19 infections? The first question is being addressed by a survey created SHARP, a European Clinical Research Collaboration on severe asthma- people with asthma from the UK and Europe will be invited to complete the survey. To complement this, the investigators propose a UK pilot study (carried out in up to four severe asthma centres) to measure immune responses following vaccination in 200 people with severe asthma. The investigators will invite 120 people receiving asthma biologics (monoclonal antibodies), 40 people receiving asthma inhalers, 40 people needing daily steroid tablets to control their asthma, and 50 age-matched healthy people. Immune responses will be studied using a simple home blood antibody test posted to participants. By pricking their finger, patients will collect 5-6 drops of blood in a small test tube and will post back on the same day to a laboratory in London. Tests will be done twice: after the first and second vaccine doses.
The study will help us understand if the body's immune response to the COVID-19 vaccine is different in people with severe asthma who are on different treatments to manage their symptoms.
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：Thomas Bower
- 電話番号：02381204989
- メール：thomas.bower@uhs.nhs.uk
研究場所
-
-
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Exeter、イギリス、EX2 5DW
- まだ募集していません
- Royal Devon and Exeter NHS Foundation Trust
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コンタクト：
- Lisa Treeby
- 電話番号：01392 403814
- メール：lisa.treeby@nhs.net
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コンタクト：
- Matthew Masoli
- メール：matthew.masoli@nhs.net
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主任研究者：
- Matthew Masoli
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Glasgow、イギリス、G12 0YN
- 募集
- Gartnavel General Hospital
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主任研究者：
- Rekha Chaudhuri
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コンタクト：
- Rekha Chaudhuri
- メール：Rekha.Chaudhuri@ggc.scot.nhs.uk
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コンタクト：
- Kayleigh Mckenna
- メール：Kayleigh.McKenna@ggc.scot.nhs.uk
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London、イギリス、SE1 9RT
- まだ募集していません
- Guy's and St Thomas' NHS Trust Foundation
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コンタクト：
- Gill Arbane
- メール：gill.arbane@gstt.nhs.uk
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コンタクト：
- Mathew Furtado
- メール：Mathew.Furtado@gstt.nhs.uk
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主任研究者：
- David Jackson, MRCP MSc PhD
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Newcastle、イギリス、NE1 4LP
- まだ募集していません
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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主任研究者：
- Simon Doe
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コンタクト：
- Simon Doe
- メール：simon.doe@nhs.net
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コンタクト：
- Jamie Brown
- メール：jamie.brown3@nhs.net
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-
Hampshire
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Southampton、Hampshire、イギリス、SO16 6YD
- 募集
- University Hospital Southampton Nhs Foundation Trust
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コンタクト：
- Thomas Bower
- 電話番号：02381204989
- メール：thomas.bower@uhs.nhs.uk
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主任研究者：
- Hitasha Rupani
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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:
- Age ≥ 16 years
For asthma patients:
- Diagnosis of severe asthma (based on ATS/ERS consensus criteria)
- Group A: Currently receiving an asthma biologic with treatment having started at least 3 months before first COVID-19 vaccine
- Group B: on maintenance oral steroids at a dose of ≥5mg prednisolone (or equivalent) per day (at the time of first COVID-19 vaccine)
- Group C: not on asthma biologic or maintenance oral steroids (at the time of vaccination) or stopped ≥3 months prior to first COVID-19 vaccine
Exclusion criteria:
- Current pregnancy or planning a pregnancy within the next 6 months
- Current malignancy
- Diagnosis of immunodeficiency requiring treatment
Additional exclusion criteria for asthma patients:
- Group A: maintenance oral steroids at the time of first COVID-19 vaccine
- Group B: on an asthma biologic at the time of first COVID-19 vaccine
Additional exclusion criteria for healthy controls cohort (as assessed by research team):
- No history of asthma or significant other lung disease
- Severe chronic inflammatory disease
- Severe cardiac disease
- Diabetes
- Previous proven COVID-19 infection
- Inability to provide informed consent
- Unwilling to have vaccination
- Participation in another clinical trial involving an investigational medicinal product (IMP).
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
- 観測モデル：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Asthma biologics
120 people receiving asthma biologics (monoclonal antibodies)
|
Not Interventional their treatments are their routine NHS care
|
|
Asthma inhalers
40 people receiving asthma inhalers
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Not Interventional their treatments are their routine NHS care
|
|
Steroid tablets
40 people needing daily steroid tablets to control their asthma
|
Not Interventional their treatments are their routine NHS care
|
|
Healthy Control
50 age-matched healthy people
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Not Interventional their treatments are their routine NHS care
|
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 |
|---|---|---|
|
Measured immune response
時間枠：12 Months
|
To compare the measured immune response to vaccination in patients with 200 severe asthma and 50 healthy individuals.
A positive response will be defined as IgG ≥0.201.
|
12 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Range of immune responses
時間枠：12 Months
|
To evaluate the range of immune responses measured by IgG titres (very high: >1.25, high: 0.751-1.25,
medium: 0.401-0.75
or low: 0.201-0.4) in patients with 200 severe asthma and compare this with 50 healthy individuals
|
12 Months
|
|
Differences in responses between treatment groups
時間枠：12 Months
|
To identify any differences in responses between patients treated with biologics, standard inhaler treatment with/without maintenance oral corticosteroids (mOCS)
|
12 Months
|
|
Differences between responses within the three biologics
時間枠：12 Months
|
To identify any differences between responses to vaccines amongst patient groups treated with three biologics (anti-IgE Omalizumab, anti-IL-5 Mepolizumab, and anti-IL-5receptor Benralizumab)
|
12 Months
|
協力者と研究者
捜査官
- 主任研究者：Hitasha Rupani、University Hospital Southampton Nhs Foundation Trust
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
- RHM MED1777
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?
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