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

August 12, 2015 updated by: Hvivo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Virus shedding defined as area under the curve
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms of respiratory tract infection
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvivo

Investigators

  • Principal Investigator: Bryan Murray, MD, PI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • RVL-CS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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