Severe Asthma Covid Vaccine Response Study

Last updated: November 22, 2021
Sponsor: University Hospital Southampton NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05130320
RHM MED1777
  • Ages 16-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Age ≥ 16 years
  2. For asthma patients:
  3. Diagnosis of severe asthma (based on ATS/ERS consensus criteria)
  4. Group A: Currently receiving an asthma biologic with treatment having started atleast 3 months before first COVID-19 vaccine
  5. Group B: on maintenance oral steroids at a dose of ≥5mg prednisolone (orequivalent) per day (at the time of first COVID-19 vaccine)
  6. Group C: not on asthma biologic or maintenance oral steroids (at the time ofvaccination) or stopped ≥3 months prior to first COVID-19 vaccine

Exclusion

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:
  5. Group A: maintenance oral steroids at the time of first COVID-19 vaccine
  6. Group B: on an asthma biologic at the time of first COVID-19 vaccine
  7. Additional exclusion criteria for healthy controls cohort (as assessed by researchteam):
  8. No history of asthma or significant other lung disease
  9. Severe chronic inflammatory disease
  10. Severe cardiac disease
  11. Diabetes
  12. Previous proven COVID-19 infection
  13. Inability to provide informed consent
  14. Unwilling to have vaccination
  15. Participation in another clinical trial involving an investigational medicinal product (IMP).

Study Design

Total Participants: 250
Study Start date:
May 06, 2021
Estimated Completion Date:
March 31, 2022

Study 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.

Connect with a study center

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Active - Recruiting

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Gartnavel General Hospital

    Glasgow, G12 0YN
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' NHS Trust Foundation

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE1 4LP
    United Kingdom

    Site Not Available

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