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Severe Asthma Covid Vaccine Response Study (SHINE)

22. november 2021 opdateret af: University Hospital Southampton NHS Foundation Trust

SHINE: Severe Asthma Covid Vaccine Response Study

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
      • Exeter, Det Forenede Kongerige, EX2 5DW
        • Ikke rekrutterer endnu
        • Royal Devon and Exeter NHS Foundation Trust
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Matthew Masoli
      • Glasgow, Det Forenede Kongerige, G12 0YN
      • London, Det Forenede Kongerige, SE1 9RT
      • Newcastle, Det Forenede Kongerige, NE1 4LP
        • Ikke rekrutterer endnu
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Ledende efterforsker:
          • Simon Doe
        • Kontakt:
        • Kontakt:
    • Hampshire
      • Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
        • Rekruttering
        • University Hospital Southampton NHS Foundation Trust
        • Kontakt:
        • Ledende efterforsker:
          • Hitasha Rupani

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 100 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Asthma biologics
120 people receiving asthma biologics (monoclonal antibodies)
Andet: Not Interventional their treatments are their routine NHS care
Not Interventional their treatments are their routine NHS care
Asthma inhalers
40 people receiving asthma inhalers
Andet: Not Interventional their treatments are their routine NHS care
Not Interventional their treatments are their routine NHS care
Steroid tablets
40 people needing daily steroid tablets to control their asthma
Andet: Not Interventional their treatments are their routine NHS care
Not Interventional their treatments are their routine NHS care
Healthy Control
50 age-matched healthy people
Andet: Not Interventional their treatments are their routine NHS care
Not Interventional their treatments are their routine NHS care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measured immune response
Tidsramme: 12 Months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Range of immune responses
Tidsramme: 12 Months
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
Tidsramme: 12 Months
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
Tidsramme: 12 Months
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Southampton NHS Foundation Trust

Samarbejdspartnere

Asthma Allergy & Inflammation Research Trust

Efterforskere

  • Ledende efterforsker: Hitasha Rupani, University Hospital Southampton NHS Foundation Trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. maj 2021

Primær færdiggørelse (Forventet)

1. marts 2022

Studieafslutning (Forventet)

1. marts 2022

Datoer for studieregistrering

Først indsendt

7. maj 2021

Først indsendt, der opfyldte QC-kriterier

22. november 2021

Først opslået (Faktiske)

23. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RHM MED1777

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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