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
| Registry | NCT02522832 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, basic science |
| Enrollment | 17 (Actual) |
| Sponsor | Hvivo (Industry) |
| Conditions | Rhinovirus |
| Interventions | Titre 1, Titre 2, Titre 3 (Other) |
| Dates | start 2013-01-01, primary completion 2014-07-01, completion 2014-12-01, first posted 2015-08-13, last updated 2015-08-13 |
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All trials for Rhinovirus All trials of Titre 1 All trials of Titre 2
A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.
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.
An 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Titre 1 | Experimental | Other: Titre 1 | Low infectious titre of innoculum |
| Titre 2 | Experimental | Other: Titre 2 | Medium infectious titre of innoculum |
| Titre 3 | Experimental | Other: Titre 3 | High infectious titre of innoculum |
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests. * Female subjects were required to provide of a history of reliable contraceptive practice. Exclusion Criteria:included; * asthma, * hypersensitivity to mercurials or chicken eggs, * anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, chronic nasopharyngeal complaints, * abnormal electrocardiogram (ECG), * febrile illness or significant symptoms of upper respiratory infection on the day of * Subjects using medication or other products for rhinitis or nasal congestion, * Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start. * Subjects agreed not to smoke during the quarantine phase.