SHINE: Severe Asthma Covid Vaccine Response Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Measured immune response
研究概览
简要总结
This study aims to employ a simple finger-prick home test to detect post vaccination antibody levels. The investigators will compare antibody responses in patients with severe asthma on varying treatment regimes (biologics, daily steroids, inhalers-only) with healthy, age-matched controls to study if the magnitude and range of responses vary between severe asthmatics and healthy individuals.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 100 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Measured immune response
时间窗: 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.
次要结局
- Range of immune responses(12 Months)
- Differences in responses between treatment groups(12 Months)
- Differences between responses within the three biologics(12 Months)
