RhinovirusNCT02522832
Discovering New Treatments for Asthma and COPD. A New Human Rhinvovirus for Human Challenge
A study testing Titre 1, Titre 2 and Titre 3 in people with Rhinovirus, run by Hvivo.
Trial summary
A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinovirus
- What is being tested?
- Titre 1, Titre 2 and Titre 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.
Read the 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.
- Conditions
- Rhinovirus
- Being tested
- Titre 1, Titre 2, Titre 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titre 1Other
Virus infection
Titre 2Other
Virus infection
Titre 3Other
Virus infection
| Study group | Role | What they receive |
|---|---|---|
| Titre 1 | Experimental | Low infectious titre of innoculum Receives: Other: Titre 1 |
| Titre 2 | Experimental | Medium infectious titre of innoculum Receives: Other: Titre 2 |
| Titre 3 | Experimental | High infectious titre of innoculum Receives: Other: Titre 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus shedding defined as area under the curve
Measured: 10 days
Secondary outcomes (1)
Symptoms of respiratory tract infection
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Murray, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522832
- Sponsor's protocol ID
- RVL-CS-002
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fullen DJ, Murray B, Mori J, Catchpole A, Borley DW, Murray EJ, Balaratnam G, Gilbert A, Mann A, Hughes F, Lambkin-Williams R. A Tool for Investigating Asthma and COPD Exacerbations: A Newly Manufactured and Well Characterised GMP Wild-Type Human Rhinovirus for Use in the Human Viral Challenge Model. PLoS One. 2016 Dec 9;11(12):e0166113. doi: 10.1371/journal.pone.0166113. eCollection 2016.
PubMed 27936016
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02522832
- Acronym / sponsor ID
- RVL-CS-002
- Conditions
- Rhinovirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Titre 1 | Experimental | Other: Titre 1Low infectious titre of innoculum |
| Titre 2 | Experimental | Other: Titre 2Medium infectious titre of innoculum |
| Titre 3 | Experimental | Other: Titre 3High infectious titre of innoculum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titre 1Virus infection | Other | Titre 1 |
| Titre 2Virus infection | Other | Titre 2 |
| Titre 3Virus infection | Other | Titre 3 |
Primary outcome
Virus shedding defined as area under the curve
Time frame: 10 days
1 secondary outcome
Symptoms of respiratory tract infection
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Derived from this study: PubMed 27936016Fullen DJ, Murray B, Mori J, Catchpole A, Borley DW, Murray EJ, Balaratnam G, Gilbert A, Mann A, Hughes F, Lambkin-Williams R. A Tool for Investigating Asthma and COPD Exacerbations: A Newly Manufactured and Well Characterised GMP Wild-Type Human Rhinovirus for Use in the Human Viral Challenge Model. PLoS One. 2016 Dec 9;11(12):e0166113. doi: 10.1371/journal.pone.0166113. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Murray, MD principal investigator
PI
Questions about this trial
What is this clinical trial studying?
A study testing Titre 1, Titre 2 and Titre 3 in people with Rhinovirus, run by Hvivo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virus shedding defined as area under the curve (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.