Severe Asthma Covid Vaccine Response Study

University Hospital Southampton NHS Foundation Trust250 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Coronavirus Antibody Levels

Interventions

Not Interventional their treatments are their routine NHS careOTHER

Not Interventional their treatments are their routine NHS care

Eligibility

Sex: ALLMin age: 16 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. Age ≥ 16 years 2. For asthma patients: 1. Diagnosis of severe asthma (based on ATS/ERS consensus criteria) 2. Group A: Currently receiving an asthma biologic with treatment having started at least 3 months before first COVID-19 vaccine 3. Group B: on maintenance oral steroids at a dose of ≥5mg prednisolone (or equivalent) per day (at the time of first COVID-19 vaccine) 4. 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: 1. Current pregnancy or planning a pregnancy within the next 6 months 2. Current malignancy 3. Diagnosis of immunodeficiency requiring treatment 4. Additional exclusion criteria for asthma patients: 1. Group A: maintenance oral steroids at the time of first COVID-19 vaccine 2. Group B: on an asthma biologic at the time of first COVID-19 vaccine 5. Additional exclusion criteria for healthy controls cohort (as assessed by research team): 1. No history of asthma or significant other lung disease 2. Severe chronic inflammatory disease 3. Severe cardiac disease 4. Diabetes 6. Previous proven COVID-19 infection 7. Inability to provide informed consent 8. Unwilling to have vaccination 9. Participation in another clinical trial involving an investigational medicinal product (IMP).

Locations (5)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

RECRUITING

Royal Devon and Exeter NHS Foundation Trust

Exeter, United Kingdom

NOT_YET_RECRUITING

Gartnavel General Hospital

Glasgow, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 12 Months

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: 12 Months

Central Contacts

Thomas Bower

CONTACT

02381204989 thomas.bower@uhs.nhs.uk

Data from ClinicalTrials.gov

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