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| Name | Class |
|---|---|
| Asthma Allergy & Inflammation Research Trust | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma biologics | 120 people receiving asthma biologics (monoclonal antibodies) |
| |
| Asthma inhalers | 40 people receiving asthma inhalers |
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| Steroid tablets | 40 people needing daily steroid tablets to control their asthma |
| |
| Healthy Control | 50 age-matched healthy people |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not Interventional their treatments are their routine NHS care | Other | Not Interventional their treatments are their routine NHS care |
|
| 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 |
| 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 |
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Inclusion criteria:
Age ≥ 16 years
For asthma patients:
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:
Additional exclusion criteria for healthy controls cohort (as assessed by research team):
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).
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The study will recruit patients that attended the severe asthma clinic. To recruit age-matched controls we will randomly approach the patients and ask if their partners (or age-matched family members or friends) would like to participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Bower | Contact | 02381204989 | thomas.bower@uhs.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Hitasha Rupani | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23450529 | Result | Cates CJ, Rowe BH. Vaccines for preventing influenza in people with asthma. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD000364. doi: 10.1002/14651858.CD000364.pub4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 23, 2024 | |
| Reset | Aug 1, 2024 | |
| Release | Oct 2, 2024 | |
| Reset | Nov 27, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 23, 2024 | Aug 1, 2024 | |||
| Oct 2, 2024 |
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Blood Samples
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 |
| Royal Devon and Exeter NHS Foundation Trust | Not yet recruiting | Exeter | EX2 5DW | United Kingdom |
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| Gartnavel General Hospital | Recruiting | Glasgow | G12 0YN | United Kingdom |
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| Guy's and St Thomas' NHS Trust Foundation | Not yet recruiting | London | SE1 9RT | United Kingdom |
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| The Newcastle upon Tyne Hospitals NHS Foundation Trust | Not yet recruiting | Newcastle | NE1 4LP | United Kingdom |
|
| Nov 27, 2024 |