Severe Asthma Covid Vaccine Response Study (SHINE)
SHINE: Severe Asthma Covid Vaccine Response Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Thomas Bower
- Numéro de téléphone: 02381204989
- E-mail: thomas.bower@uhs.nhs.uk
Lieux d'étude
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-
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Exeter, Royaume-Uni, EX2 5DW
- Pas encore de recrutement
- Royal Devon and Exeter NHS Foundation Trust
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Contact:
- Lisa Treeby
- Numéro de téléphone: 01392 403814
- E-mail: lisa.treeby@nhs.net
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Contact:
- Matthew Masoli
- E-mail: matthew.masoli@nhs.net
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Chercheur principal:
- Matthew Masoli
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Glasgow, Royaume-Uni, G12 0YN
- Recrutement
- Gartnavel General Hospital
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Chercheur principal:
- Rekha Chaudhuri
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Contact:
- Rekha Chaudhuri
- E-mail: Rekha.Chaudhuri@ggc.scot.nhs.uk
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Contact:
- Kayleigh Mckenna
- E-mail: Kayleigh.McKenna@ggc.scot.nhs.uk
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London, Royaume-Uni, SE1 9RT
- Pas encore de recrutement
- Guy's and St Thomas' NHS Trust Foundation
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Contact:
- Gill Arbane
- E-mail: gill.arbane@gstt.nhs.uk
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Contact:
- Mathew Furtado
- E-mail: Mathew.Furtado@gstt.nhs.uk
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Chercheur principal:
- David Jackson, MRCP MSc PhD
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Newcastle, Royaume-Uni, NE1 4LP
- Pas encore de recrutement
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Chercheur principal:
- Simon Doe
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Contact:
- Simon Doe
- E-mail: simon.doe@nhs.net
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Contact:
- Jamie Brown
- E-mail: jamie.brown3@nhs.net
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Hampshire
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Southampton, Hampshire, Royaume-Uni, SO16 6YD
- Recrutement
- University Hospital Southampton NHS Foundation Trust
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Contact:
- Thomas Bower
- Numéro de téléphone: 02381204989
- E-mail: thomas.bower@uhs.nhs.uk
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Chercheur principal:
- Hitasha Rupani
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion criteria:
- Age ≥ 16 years
For asthma patients:
- Diagnosis of severe asthma (based on ATS/ERS consensus criteria)
- Group A: Currently receiving an asthma biologic with treatment having started at least 3 months before first COVID-19 vaccine
- Group B: on maintenance oral steroids at a dose of ≥5mg prednisolone (or equivalent) per day (at the time of first COVID-19 vaccine)
- 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:
- Current pregnancy or planning a pregnancy within the next 6 months
- Current malignancy
- Diagnosis of immunodeficiency requiring treatment
Additional exclusion criteria for asthma patients:
- Group A: maintenance oral steroids at the time of first COVID-19 vaccine
- Group B: on an asthma biologic at the time of first COVID-19 vaccine
Additional exclusion criteria for healthy controls cohort (as assessed by research team):
- No history of asthma or significant other lung disease
- Severe chronic inflammatory disease
- Severe cardiac disease
- Diabetes
- 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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Asthma biologics
120 people receiving asthma biologics (monoclonal antibodies)
|
Not Interventional their treatments are their routine NHS care
|
|
Asthma inhalers
40 people receiving asthma inhalers
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Not Interventional their treatments are their routine NHS care
|
|
Steroid tablets
40 people needing daily steroid tablets to control their asthma
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Not Interventional their treatments are their routine NHS care
|
|
Healthy Control
50 age-matched healthy people
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Not Interventional their treatments are their routine NHS care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measured immune response
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Range of immune responses
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Hitasha Rupani, University Hospital Southampton NHS Foundation Trust
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RHM MED1777
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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