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
Study 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.
Summary of Results
The COVID vaccines have helped reduce the risk of becoming infected with COVID and the severity of COVID infection. However, concern remained about the extent of protection in people with diseases such as asthma. The SHINE study, funded by the AAIR Charity in Southampton and AstraZeneca and supported by Southampton BRC, was set up during the peak of the pandemic and involved asthma experts from Southampton, London and Glasgow and was led by Dr Hitasha Rupani, Lead of the Severe Asthma Service at University Hospital Southampton.
The study investigated if people with severe asthma developed the same level of protection (also known as immune response) after vaccination as people without asthma. In particular, the study looked at whether treatments used in severe asthma affected the immune response, focusing on biologics for asthma (omalizumab, mepolizumab and benralizumab) and steroids, whether given orally (prednisolone tablets) or via inhalers.
The study looked at the ability of the immune system to produce protective antibodies (proteins that help protect from infection) after vaccination using a finger-prick blood test developed by Virtus Respiratory Research Ltd from London. People with severe asthma and healthy people without asthma had these tests in the comfort and safety of their home and then posted the tests to the laboratory in London.
During the COVID vaccination program, people were initially given 2 doses of the vaccine and then a 3rd (booster) dose was introduced. Since then, many people have had regular boosters. In the study, levels of antibodies were measured after 2 doses of the vaccine and after the 3rd dose. 129 people with severe asthma and 57 people without asthma participated in the study.
The results of the study showed that after the first 2 doses of the vaccine, people with severe asthma had lower antibody levels compared to people without asthma. However, after the 3rd vaccine dose (the booster vaccine) was given, people with severe asthma had similar and good levels of antibodies as people without asthma. In particular, biologics or steroid inhalers did not affect the immune response to COVID vaccines.
This is an important finding as it will help reassure people with severe asthma and teams who care for people with severe asthma that asthma biologics or steroid inhalers do not affect the immune protection after COVID vaccines. Our results also reinforce the need for booster vaccines.
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