Severe Asthma Covid Vaccine Response Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
SHINE: Severe Asthma Covid Vaccine Response Study

Conditions
-----------------
Coronavirus Antibody Levels

Intervention / Treatment
-----------------
* Other: Not Interventional their treatments are their routine NHS care


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma biologics<br>120 people receiving asthma biologics (monoclonal antibodies) | Other: Not Interventional their treatments are their routine NHS care<br>* Not Interventional their treatments are their routine NHS care<br>|
| Asthma inhalers<br>40 people receiving asthma inhalers | Other: Not Interventional their treatments are their routine NHS care<br>* Not Interventional their treatments are their routine NHS care<br>|
| Steroid tablets<br>40 people needing daily steroid tablets to control their asthma | Other: Not Interventional their treatments are their routine NHS care<br>* Not Interventional their treatments are their routine NHS care<br>|
| Healthy Control<br>50 age-matched healthy people | Other: Not Interventional their treatments are their routine NHS care<br>* Not Interventional their treatments are their routine NHS care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measured immune response | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of immune responses | 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 | 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 | 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 |