HealthyPhase 1NCT01466738
A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers
A Phase 1 study testing HRV-16 (100 TCID50) and HRV-16 (1000 TCID50) in people with Healthy, run by Centocor Ortho Biotech Services, L.L.C. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and clinical characteristics of a quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16 will be subsequently used in viral challenge studies with new compounds that are intended to treat respiratory diseases. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HRV-16 (100 TCID50) and HRV-16 (1000 TCID50)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2011
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Demonstrate an understanding of the study and sign an informed consent form prior to any study-related procedures
- Healthy with no clinically significant abnormalities as determined by medical history
- Women must be neither pregnant nor lactating (producing breast milk) and have a negative urine pregnancy test at Screening Visit 1
- Women of child-bearing potential and all men must agree to use adequate birth control measures (as determined by the investigator) and must agree to continue to use such measures and not plan a pregnancy until after the Day 6 visit
- Men must agree not to donate sperm during the study through the Day 6 visit
Who cannot join
- Have a documented serum-neutralizing antibody titer of > 2-fold dilution to HRV-16 in the blood sample within approximately 40 days of Screening Visit 2
- Live with a family member who cares for the elderly, infants, or small children (eg, nursing home or day care provider), or live with someone who has a chronic lung disease, premature infant, or immunocompromised individual
- Require a prescription or over-the-counter medication on a regular basis (3 or more times per week), except contraceptive preparations, hormone replacement therapy, or topical acne medication
- Have a history of chronic disease that the Investigator believes are clinically significant
- Have a history of chronic headaches (eg frequent migraines, cluster headaches) with 3 or more headaches per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characterization of a Human Rhinovirus Type 16 Challenge Pool Following Intranasal Administration to Healthy Adult Subjects
The purpose of this study is to evaluate the safety and clinical characteristics of a quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16 will be subsequently used in viral challenge studies with new compounds that are intended to treat respiratory diseases.
Read the detailed description
This is an open-label study in which all participants know the investigational substance being tested. Participants will be inoculated in the nose with HRV-16 and evaluated for the occurrence of cold symptoms and other indicators. There will be 3 phases: a screening phase, an HRV-16 infection phase, and a follow-up phase. The dose of virus being tested in this study has been previously used in other challenge studies. The total length of participation in the study will be about 4 weeks. Participant safety will be monitored.
- Conditions
- Healthy
- Being tested
- HRV-16 (100 TCID50), HRV-16 (1000 TCID50)
- Keywords
- Healthy volunteer, Rhinovirus, Cold virus, HRV-16
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV-16 (100 TCID50)Biological
Each volunteer will receive a single administration of 100 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.
HRV-16 (1000 TCID50)Biological
Each volunteer will receive a single administration of 1000 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.
| Study group | Role | What they receive |
|---|---|---|
| HRV-16 (100 TCID50) | Experimental | Not described Receives: Biological: HRV-16 (100 TCID50) |
| HRV-16 (1000 TCID50) | Experimental | Not described Receives: Biological: HRV-16 (1000 TCID50) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms to HRV-16
Clinical symptoms to HRV-16 will be assessed using the Cold Symptom Assessment form, which is a 5-point scale of the severity of cold symptoms.
Measured: 6 days
Serological Response
Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.
Measured: Approximately 4 weeks
Secondary outcomes (1)
The number of adverse events
Measured: Approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor Ortho Biotech Services, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Centocor Ortho Biotech Services, L.L.C. Clinical Trial, Study director, Centocor Ortho Biotech Services, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466738
- Sponsor's protocol ID
- CR018733
- Other IDs
- NOCOMPOUNDASH1001
- Status last verified
- Feb 2012
- First submitted
- 4 Nov 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characterization of a Human Rhinovirus Type 16 Challenge Pool Following Intranasal Administration to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01466738
- Acronym / sponsor ID
- CR018733
- Conditions
- Healthy
- Keywords
- Healthy volunteer, Rhinovirus, Cold virus, HRV-16
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centocor Ortho Biotech Services, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Nov 2011 (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.
The purpose of this study is to evaluate the safety and clinical characteristics of a quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16 will be subsequently used in viral challenge studies with new compounds that are intended to treat respiratory diseases.
Detailed description
This is an open-label study in which all participants know the investigational substance being tested. Participants will be inoculated in the nose with HRV-16 and evaluated for the occurrence of cold symptoms and other indicators. There will be 3 phases: a screening phase, an HRV-16 infection phase, and a follow-up phase. The dose of virus being tested in this study has been previously used in other challenge studies. The total length of participation in the study will be about 4 weeks. Participant safety will be monitored.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV-16 (100 TCID50) | Experimental | Biological: HRV-16 (100 TCID50) |
| HRV-16 (1000 TCID50) | Experimental | Biological: HRV-16 (1000 TCID50) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Demonstrate an understanding of the study and sign an informed consent form prior to any study-related procedures
- Healthy with no clinically significant abnormalities as determined by medical history
- Women must be neither pregnant nor lactating (producing breast milk) and have a negative urine pregnancy test at Screening Visit 1
- Women of child-bearing potential and all men must agree to use adequate birth control measures (as determined by the investigator) and must agree to continue to use such measures and not plan a pregnancy until after the Day 6 visit
- Men must agree not to donate sperm during the study through the Day 6 visit
Key exclusion criteria (5 listed)
- Have a documented serum-neutralizing antibody titer of > 2-fold dilution to HRV-16 in the blood sample within approximately 40 days of Screening Visit 2
- Live with a family member who cares for the elderly, infants, or small children (eg, nursing home or day care provider), or live with someone who has a chronic lung disease, premature infant, or immunocompromised individual
- Require a prescription or over-the-counter medication on a regular basis (3 or more times per week), except contraceptive preparations, hormone replacement therapy, or topical acne medication
- Have a history of chronic disease that the Investigator believes are clinically significant
- Have a history of chronic headaches (eg frequent migraines, cluster headaches) with 3 or more headaches per week
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 |
|---|---|---|
| HRV-16 (100 TCID50)Each volunteer will receive a single administration of 100 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations. | Biological | HRV-16 (100 TCID50) |
| HRV-16 (1000 TCID50)Each volunteer will receive a single administration of 1000 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations. | Biological | HRV-16 (1000 TCID50) |
Primary outcome
Clinical symptoms to HRV-16
Time frame: 6 days
Clinical symptoms to HRV-16 will be assessed using the Cold Symptom Assessment form, which is a 5-point scale of the severity of cold symptoms.
Serological Response
Time frame: Approximately 4 weeks
Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.
1 secondary outcome
The number of adverse events
Time frame: Approximately 4 weeks
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 22 Feb 2012.
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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.
Centocor Ortho Biotech Services, L.L.C. Clinical Trial study director
Centocor Ortho Biotech Services, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRV-16 (100 TCID50) and HRV-16 (1000 TCID50) in people with Healthy, run by Centocor Ortho Biotech Services, L.L.C. at 1 site in United States.
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 5 inclusion and 5 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical symptoms to HRV-16 (time frame: 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2012.