- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05130320
Severe Asthma Covid Vaccine Response Study (SHINE)
SHINE: Severe Asthma Covid Vaccine Response Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Thomas Bower
- Número de teléfono: 02381204989
- Correo electrónico: thomas.bower@uhs.nhs.uk
Ubicaciones de estudio
-
-
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Exeter, Reino Unido, EX2 5DW
- Aún no reclutando
- Royal Devon and Exeter NHS Foundation Trust
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Contacto:
- Lisa Treeby
- Número de teléfono: 01392 403814
- Correo electrónico: lisa.treeby@nhs.net
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Contacto:
- Matthew Masoli
- Correo electrónico: matthew.masoli@nhs.net
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Investigador principal:
- Matthew Masoli
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Glasgow, Reino Unido, G12 0YN
- Reclutamiento
- Gartnavel General Hospital
-
Investigador principal:
- Rekha Chaudhuri
-
Contacto:
- Rekha Chaudhuri
- Correo electrónico: Rekha.Chaudhuri@ggc.scot.nhs.uk
-
Contacto:
- Kayleigh Mckenna
- Correo electrónico: Kayleigh.McKenna@ggc.scot.nhs.uk
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London, Reino Unido, SE1 9RT
- Aún no reclutando
- Guy's and St Thomas' NHS Trust Foundation
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Contacto:
- Gill Arbane
- Correo electrónico: gill.arbane@gstt.nhs.uk
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Contacto:
- Mathew Furtado
- Correo electrónico: Mathew.Furtado@gstt.nhs.uk
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Investigador principal:
- David Jackson, MRCP MSc PhD
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Newcastle, Reino Unido, NE1 4LP
- Aún no reclutando
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Investigador principal:
- Simon Doe
-
Contacto:
- Simon Doe
- Correo electrónico: simon.doe@nhs.net
-
Contacto:
- Jamie Brown
- Correo electrónico: jamie.brown3@nhs.net
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-
Hampshire
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Southampton, Hampshire, Reino Unido, SO16 6YD
- Reclutamiento
- University Hospital Southampton NHS Foundation Trust
-
Contacto:
- Thomas Bower
- Número de teléfono: 02381204989
- Correo electrónico: thomas.bower@uhs.nhs.uk
-
Investigador principal:
- Hitasha Rupani
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
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
|
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
|
Healthy Control
50 age-matched healthy people
|
Not Interventional their treatments are their routine NHS care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Measured immune response
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Range of immune responses
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hitasha Rupani, University Hospital Southampton NHS Foundation Trust
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RHM MED1777
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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