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

Rhinovirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522832
• Other study ID #: RVL-CS-002
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: August 12, 2015
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Hvivo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Rhinovirus

Intervention

Other:
• Titre 1
Virus infection
• Titre 2
Virus infection
• Titre 3
Virus infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hvivo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virus shedding defined as area under the curve		10 days	No
Secondary	Symptoms of respiratory tract infection		10 days	No