Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT02522832
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2015-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discovering New Treatments for Asthma and COPD. A New Human Rhinvovirus for Human Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virus shedding defined as area under the curve', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Symptoms of respiratory tract infection', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rhinovirus']}, 'referencesModule': {'references': [{'pmid': '27936016', 'type': 'DERIVED', 'citation': 'Fullen DJ, Murray B, Mori J, Catchpole A, Borley DW, Murray EJ, Balaratnam G, Gilbert A, Mann A, Hughes F, Lambkin-Williams R. A Tool for Investigating Asthma and COPD Exacerbations: A Newly Manufactured and Well Characterised GMP Wild-Type Human Rhinovirus for Use in the Human Viral Challenge Model. PLoS One. 2016 Dec 9;11(12):e0166113. doi: 10.1371/journal.pone.0166113. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.', 'detailedDescription': "Human Rhinovirus infection is an important precursor to asthma and chronic obstructive pulmonary disease exacerbations and the Human Viral Challenge model may provide a powerful tool in studying these and other chronic respiratory diseases. In this study we have reported the production and human characterisation of a new HRV-16 challenge virus produced specifically for this purpose.\n\nAn HRV-16 isolate from an 18 year old experimentally infected healthy female volunteer (University of Virginia Children's Hospital, USA) was obtained with appropriate medical history and consent. We manufactured a new HRV-16 stock by minimal passage in a WI-38 cell line under Good Manufacturing Practice conditions. Having first subjected the stock to rigorous adventitious agent testing and determining the virus suitability for human use, we conducted an initial safety and pathogenicity clinical study in adult volunteers in our dedicated clinical quarantine facility in London."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.\n* Female subjects were required to provide of a history of reliable contraceptive practice.\n\nExclusion Criteria:included;\n\n* asthma,\n* hypersensitivity to mercurials or chicken eggs,\n* anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, chronic nasopharyngeal complaints,\n* abnormal electrocardiogram (ECG),\n* febrile illness or significant symptoms of upper respiratory infection on the day of\n* Subjects using medication or other products for rhinitis or nasal congestion,\n* Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.\n* Subjects agreed not to smoke during the quarantine phase.'}, 'identificationModule': {'nctId': 'NCT02522832', 'briefTitle': 'Discovering New Treatments for Asthma and COPD. A New Human Rhinvovirus for Human Challenge', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hvivo'}, 'officialTitle': 'Discovering New Treatments for Asthma and COPD. The Use of the Human Viral Challenge Model With a Newly Manufactured and Characterised GMP Wild-Type Human Rhinovirus', 'orgStudyIdInfo': {'id': 'RVL-CS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Titre 1', 'description': 'Low infectious titre of innoculum', 'interventionNames': ['Other: Titre 1']}, {'type': 'EXPERIMENTAL', 'label': 'Titre 2', 'description': 'Medium infectious titre of innoculum', 'interventionNames': ['Other: Titre 2']}, {'type': 'EXPERIMENTAL', 'label': 'Titre 3', 'description': 'High infectious titre of innoculum', 'interventionNames': ['Other: Titre 3']}], 'interventions': [{'name': 'Titre 1', 'type': 'OTHER', 'description': 'Virus infection', 'armGroupLabels': ['Titre 1']}, {'name': 'Titre 2', 'type': 'OTHER', 'description': 'Virus infection', 'armGroupLabels': ['Titre 2']}, {'name': 'Titre 3', 'type': 'OTHER', 'description': 'Virus infection', 'armGroupLabels': ['Titre 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bryan Murray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvivo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}