Rhinovirus
Conditions
Brief summary
A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.
Detailed description
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.
Interventions
OTHERTitre 1
Virus infection
OTHERTitre 2
Virus infection
OTHERTitre 3
Virus infection
Sponsors
Hvivo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virus shedding defined as area under the curve | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms of respiratory tract infection | 10 days |
Outcome results
None listed