Severe Asthma Covid Vaccine Response Study (SHINE)
SHINE: Severe Asthma Covid Vaccine Response Study
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Thomas Bower
- 전화번호: 02381204989
- 이메일: thomas.bower@uhs.nhs.uk
연구 장소
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-
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Exeter, 영국, EX2 5DW
- 아직 모집하지 않음
- Royal Devon and Exeter NHS Foundation Trust
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연락하다:
- Lisa Treeby
- 전화번호: 01392 403814
- 이메일: lisa.treeby@nhs.net
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연락하다:
- Matthew Masoli
- 이메일: matthew.masoli@nhs.net
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수석 연구원:
- Matthew Masoli
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Glasgow, 영국, G12 0YN
- 모병
- Gartnavel General Hospital
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수석 연구원:
- Rekha Chaudhuri
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연락하다:
- Rekha Chaudhuri
- 이메일: Rekha.Chaudhuri@ggc.scot.nhs.uk
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연락하다:
- Kayleigh Mckenna
- 이메일: Kayleigh.McKenna@ggc.scot.nhs.uk
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London, 영국, SE1 9RT
- 아직 모집하지 않음
- Guy's and St Thomas' NHS Trust Foundation
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연락하다:
- Gill Arbane
- 이메일: gill.arbane@gstt.nhs.uk
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연락하다:
- Mathew Furtado
- 이메일: Mathew.Furtado@gstt.nhs.uk
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수석 연구원:
- David Jackson, MRCP MSc PhD
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Newcastle, 영국, NE1 4LP
- 아직 모집하지 않음
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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수석 연구원:
- Simon Doe
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연락하다:
- Simon Doe
- 이메일: simon.doe@nhs.net
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연락하다:
- Jamie Brown
- 이메일: jamie.brown3@nhs.net
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Hampshire
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Southampton, Hampshire, 영국, SO16 6YD
- 모병
- University Hospital Southampton NHS Foundation Trust
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연락하다:
- Thomas Bower
- 전화번호: 02381204989
- 이메일: thomas.bower@uhs.nhs.uk
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수석 연구원:
- Hitasha Rupani
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Asthma biologics
120 people receiving asthma biologics (monoclonal antibodies)
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Not Interventional their treatments are their routine NHS care
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Asthma inhalers
40 people receiving asthma inhalers
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Not Interventional their treatments are their routine NHS care
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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
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Healthy Control
50 age-matched healthy people
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Not Interventional their treatments are their routine NHS care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Measured immune response
기간: 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.
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12 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Range of immune responses
기간: 12 Months
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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
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12 Months
|
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Differences in responses between treatment groups
기간: 12 Months
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To identify any differences in responses between patients treated with biologics, standard inhaler treatment with/without maintenance oral corticosteroids (mOCS)
|
12 Months
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Differences between responses within the three biologics
기간: 12 Months
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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)
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12 Months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hitasha Rupani, University Hospital Southampton NHS Foundation Trust
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RHM MED1777
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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