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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02522832
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Rhinovirus Other: Titre 1 Other: Titre 2 Other: Titre 3 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : January 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Titre 1
Low infectious titre of innoculum
Other: Titre 1
Virus infection

Experimental: Titre 2
Medium infectious titre of innoculum
Other: Titre 2
Virus infection

Experimental: Titre 3
High infectious titre of innoculum
Other: Titre 3
Virus infection

Primary Outcome Measures :
  1. Virus shedding defined as area under the curve [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Symptoms of respiratory tract infection [ Time Frame: 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02522832

Sponsors and Collaborators
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Principal Investigator: Bryan Murray, MD PI
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hvivo Identifier: NCT02522832    
Other Study ID Numbers: RVL-CS-002
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015