Severe Asthma Covid Vaccine Response Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronavirus Antibody Levels

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Asthma biologics

120 people receiving asthma biologics (monoclonal antibodies)

Not Interventional their treatments are their routine NHS care

Intervention Type OTHER

Not Interventional their treatments are their routine NHS care

Asthma inhalers

40 people receiving asthma inhalers

Not Interventional their treatments are their routine NHS care

Intervention Type OTHER

Not Interventional their treatments are their routine NHS care

Steroid tablets

40 people needing daily steroid tablets to control their asthma

Not Interventional their treatments are their routine NHS care

Intervention Type OTHER

Not Interventional their treatments are their routine NHS care

Healthy Control

50 age-matched healthy people

Not Interventional their treatments are their routine NHS care

Intervention Type OTHER

Not Interventional their treatments are their routine NHS care

Interventions

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Not Interventional their treatments are their routine NHS care

Intervention Type OTHER

Eligibility Criteria

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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

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

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).

Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hitasha Rupani

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

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.

Reference Type RESULT

PMID: 23450529 (View on PubMed)

Other Identifiers

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RHM MED1777

Identifier Type: -

Identifier Source: org_study_id

Severe Asthma Covid Vaccine Response Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Asthma biologics

Not Interventional their treatments are their routine NHS care

Asthma inhalers

Not Interventional their treatments are their routine NHS care

Steroid tablets

Not Interventional their treatments are their routine NHS care

Healthy Control

Not Interventional their treatments are their routine NHS care

Interventions

Not Interventional their treatments are their routine NHS care

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Asthma Allergy & Inflammation Research Trust

University Hospital Southampton NHS Foundation Trust

Responsible Party

Principal Investigators

Hitasha Rupani

Locations

University Hospital Southampton NHS Foundation Trust

Royal Devon and Exeter NHS Foundation Trust

Gartnavel General Hospital

Guy's and St Thomas' NHS Trust Foundation

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Countries

Central Contacts

Thomas Bower

Facility Contacts

Thomas Bower

Lisa Treeby

Matthew Masoli

Rekha Chaudhuri

Kayleigh Mckenna

Gill Arbane

Mathew Furtado

Simon Doe

Jamie Brown

References

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.

Other Identifiers

RHM MED1777