Severe Asthma Covid Vaccine Response Study (SHINE)
SHINE: Severe Asthma Covid Vaccine Response Study
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Thomas Bower
- 电话号码:02381204989
- 邮箱:thomas.bower@uhs.nhs.uk
学习地点
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Exeter、英国、EX2 5DW
- 尚未招聘
- Royal Devon and Exeter NHS Foundation Trust
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接触:
- Lisa Treeby
- 电话号码:01392 403814
- 邮箱:lisa.treeby@nhs.net
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接触:
- Matthew Masoli
- 邮箱:matthew.masoli@nhs.net
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首席研究员:
- Matthew Masoli
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Glasgow、英国、G12 0YN
- 招聘中
- Gartnavel General Hospital
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首席研究员:
- Rekha Chaudhuri
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接触:
- Rekha Chaudhuri
- 邮箱:Rekha.Chaudhuri@ggc.scot.nhs.uk
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接触:
- Kayleigh Mckenna
- 邮箱:Kayleigh.McKenna@ggc.scot.nhs.uk
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London、英国、SE1 9RT
- 尚未招聘
- Guy's and St Thomas' NHS Trust Foundation
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接触:
- Gill Arbane
- 邮箱:gill.arbane@gstt.nhs.uk
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接触:
- Mathew Furtado
- 邮箱:Mathew.Furtado@gstt.nhs.uk
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首席研究员:
- David Jackson, MRCP MSc PhD
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Newcastle、英国、NE1 4LP
- 尚未招聘
- The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
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首席研究员:
- Simon Doe
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接触:
- Simon Doe
- 邮箱:simon.doe@nhs.net
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接触:
- Jamie Brown
- 邮箱:jamie.brown3@nhs.net
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Hampshire
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Southampton、Hampshire、英国、SO16 6YD
- 招聘中
- University Hospital Southampton NHS Foundation Trust
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接触:
- Thomas Bower
- 电话号码:02381204989
- 邮箱:thomas.bower@uhs.nhs.uk
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首席研究员:
- Hitasha Rupani
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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).
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Asthma biologics
120 people receiving asthma biologics (monoclonal antibodies)
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Not Interventional their treatments are their routine NHS care
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Asthma inhalers
40 people receiving asthma inhalers
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Not Interventional their treatments are their routine NHS care
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Steroid tablets
40 people needing daily steroid tablets to control their asthma
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Not Interventional their treatments are their routine NHS care
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Healthy Control
50 age-matched healthy people
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Not Interventional their treatments are their routine NHS care
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Measured immune response
大体时间:12 Months
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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.
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12 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Range of immune responses
大体时间:12 Months
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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
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12 Months
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Differences in responses between treatment groups
大体时间:12 Months
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To identify any differences in responses between patients treated with biologics, standard inhaler treatment with/without maintenance oral corticosteroids (mOCS)
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12 Months
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Differences between responses within the three biologics
大体时间:12 Months
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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)
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12 Months
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合作者和调查者
调查人员
- 首席研究员:Hitasha Rupani、University Hospital Southampton NHS Foundation Trust
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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