Clinical trial NCT05130320: Severe Asthma Covid Vaccine Response Study
Official title: SHINE: Severe Asthma Covid Vaccine Response Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Antibody Levels
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Asthma Allergy & Inflammation Research Trust
First posted: 2021-11-23
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Measured immune response
timeFrame: 12 Months
Secondary outcomes:
measure: Range of immune responses
timeFrame: 12 Months
measure: Differences in responses between treatment groups
timeFrame: 12 Months
measure: Differences between responses within the three biologics
timeFrame: 12 Months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Trust Foundation
city: Newcastle
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Hitasha Rupani
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.