Severe asthma COVID vaccine response study: SHINE study [COVID-19]
Research type
Research Study
Full title
Severe asthma COVID vaccine response study
IRAS ID
296962
Contact name
Hitasha Rupani
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
SARS-CoV-2 and the resulting COVID-19 pandemic have 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, it is unclear how good the immune response to COVID-19 vaccines will be in people with severe asthma and if any of the severe asthma treatments influence these immune responses.
We propose a UK study (carried out in up to five severe asthma centres) to measure immune responses following vaccination (with any of the licenced COVID-19 vaccines) in 200 people with severe asthma.
We will invite 120 people receiving biologic injections, 40 people needing steroid tablets to control their asthma and 40 people who are on inhalers only and not on biologic injections or daily steroid tablets. In order to compare responses seen in people with severe asthma, we will also invite 50 age-matched healthy people to take part in the study.
Each person’s immune responses will be studied using a simple home blood antibody test posted to participants. By pricking their finger, participants will collect 5-6 drops of blood in a small test tube which they will post back, on the same day, to a laboratory in London. Tests will be done twice: 4-6 weeks after the second vaccine dose and then 4 months later.
The study will help us understand if the body’s immune response to the COVID-19 vaccine is different in people with severe asthma. It will also show if the different treatments people use to manage their asthma symptoms affect their immune response in any way. The study may also help shape future vaccination programs.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0132
Date of REC Opinion
16 Apr 2021
REC opinion
Favourable Opinion