Clinical trial NCT01466738: A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers
Official title: Clinical Characterization of a Human Rhinovirus Type 16 Challenge Pool Following Intranasal Administration to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
Rhinovirus
Cold virus
HRV-16
Lead sponsor: Centocor Ortho Biotech Services, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical symptoms to HRV-16
timeFrame: 6 days
measure: Serological Response
timeFrame: Approximately 4 weeks
Secondary outcomes:
measure: The number of adverse events
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
state: Virginia
Study officials:
affiliation: Centocor Ortho Biotech Services, L.L.C.
name: Centocor Ortho Biotech Services, L.L.C. Clinical Trial
role: STUDY_DIRECTOR
References: