Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05130320
Status:
UNKNOWN
Last Update Posted:
2021-11-23
First Post:
2021-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Severe Asthma Covid Vaccine Response Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-01', 'releaseDate': '2024-02-23'}, {'resetDate': '2024-11-27', 'releaseDate': '2024-10-02'}], 'estimatedResultsFirstSubmitDate': '2024-02-23'}}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measured immune response', 'timeFrame': '12 Months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Range of immune responses', 'timeFrame': '12 Months', 'description': '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'}, {'measure': 'Differences in responses between treatment groups', 'timeFrame': '12 Months', 'description': 'To identify any differences in responses between patients treated with biologics, standard inhaler treatment with/without maintenance oral corticosteroids (mOCS)'}, {'measure': 'Differences between responses within the three biologics', 'timeFrame': '12 Months', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Antibody Levels']}, 'referencesModule': {'references': [{'pmid': '23450529', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age ≥ 16 years\n2. For asthma patients:\n\n 1. Diagnosis of severe asthma (based on ATS/ERS consensus criteria)\n 2. Group A: Currently receiving an asthma biologic with treatment having started at least 3 months before first COVID-19 vaccine\n 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)\n 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\n\nExclusion criteria:\n\n1. Current pregnancy or planning a pregnancy within the next 6 months\n2. Current malignancy\n3. Diagnosis of immunodeficiency requiring treatment\n4. Additional exclusion criteria for asthma patients:\n\n 1. Group A: maintenance oral steroids at the time of first COVID-19 vaccine\n 2. Group B: on an asthma biologic at the time of first COVID-19 vaccine\n5. Additional exclusion criteria for healthy controls cohort (as assessed by research team):\n\n 1. No history of asthma or significant other lung disease\n 2. Severe chronic inflammatory disease\n 3. Severe cardiac disease\n 4. Diabetes\n6. Previous proven COVID-19 infection\n7. Inability to provide informed consent\n8. Unwilling to have vaccination\n9. Participation in another clinical trial involving an investigational medicinal product (IMP).'}, 'identificationModule': {'nctId': 'NCT05130320', 'acronym': 'SHINE', 'briefTitle': 'Severe Asthma Covid Vaccine Response Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'SHINE: Severe Asthma Covid Vaccine Response Study', 'orgStudyIdInfo': {'id': 'RHM MED1777'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma biologics', 'description': '120 people receiving asthma biologics (monoclonal antibodies)', 'interventionNames': ['Other: Not Interventional their treatments are their routine NHS care']}, {'label': 'Asthma inhalers', 'description': '40 people receiving asthma inhalers', 'interventionNames': ['Other: Not Interventional their treatments are their routine NHS care']}, {'label': 'Steroid tablets', 'description': '40 people needing daily steroid tablets to control their asthma', 'interventionNames': ['Other: Not Interventional their treatments are their routine NHS care']}, {'label': 'Healthy Control', 'description': '50 age-matched healthy people', 'interventionNames': ['Other: Not Interventional their treatments are their routine NHS care']}], 'interventions': [{'name': 'Not Interventional their treatments are their routine NHS care', 'type': 'OTHER', 'description': 'Not Interventional their treatments are their routine NHS care', 'armGroupLabels': ['Asthma biologics', 'Asthma inhalers', 'Healthy Control', 'Steroid tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Thomas Bower', 'role': 'CONTACT', 'email': 'thomas.bower@uhs.nhs.uk', 'phone': '02381204989'}, {'name': 'Hitasha Rupani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Lisa Treeby', 'role': 'CONTACT', 'email': 'lisa.treeby@nhs.net', 'phone': '01392 403814'}, {'name': 'Matthew Masoli', 'role': 'CONTACT', 'email': 'matthew.masoli@nhs.net'}, {'name': 'Matthew Masoli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Devon and Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rekha Chaudhuri', 'role': 'CONTACT', 'email': 'Rekha.Chaudhuri@ggc.scot.nhs.uk'}, {'name': 'Kayleigh Mckenna', 'role': 'CONTACT', 'email': 'Kayleigh.McKenna@ggc.scot.nhs.uk'}, {'name': 'Rekha Chaudhuri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gartnavel General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SE1 9RT', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Gill Arbane', 'role': 'CONTACT', 'email': 'Gill.Arbane@gstt.nhs.uk'}, {'name': 'Mathew Furtado', 'role': 'CONTACT', 'email': 'Mathew.Furtado@gstt.nhs.uk'}, {'name': 'David Jackson, MRCP MSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guy's and St Thomas' NHS Trust Foundation", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE1 4LP', 'city': 'Newcastle', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Simon Doe', 'role': 'CONTACT', 'email': 'simon.doe@nhs.net'}, {'name': 'Jamie Brown', 'role': 'CONTACT', 'email': 'jamie.brown3@nhs.net'}, {'name': 'Simon Doe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'centralContacts': [{'name': 'Thomas Bower', 'role': 'CONTACT', 'email': 'thomas.bower@uhs.nhs.uk', 'phone': '02381204989'}], 'overallOfficials': [{'name': 'Hitasha Rupani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Southampton NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asthma Allergy & Inflammation Research Trust', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-23', 'type': 'RELEASE'}, {'date': '2024-08-01', 'type': 'RESET'}, {'date': '2024-10-02', 'type': 'RELEASE'}, {'date': '2024-11-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital Southampton NHS Foundation Trust'}}}}