Discovering New Treatments for Asthma and COPD. A New Human Rhinvovirus for Human Challenge

Study Overview
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Brief Summary
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A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.

Detailed Description
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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.

Official Title
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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

Conditions
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Rhinovirus

Intervention / Treatment
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* Other: Titre 1
* Other: Titre 2
* Other: Titre 3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Titre 1<br>Low infectious titre of innoculum | Other: Titre 1<br>* Virus infection<br>|
| Experimental: Titre 2<br>Medium infectious titre of innoculum | Other: Titre 2<br>* Virus infection<br>|
| Experimental: Titre 3<br>High infectious titre of innoculum | Other: Titre 3<br>* Virus infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virus shedding defined as area under the curve |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of respiratory tract infection |  | 10 days |