Healthy
Conditions
Keywords
Healthy volunteer, Rhinovirus, Cold virus, HRV-16
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.
Interventions
BIOLOGICALHRV-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.
BIOLOGICALHRV-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.
Sponsors
Centocor Ortho Biotech Services, L.L.C.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical symptoms to HRV-16 | 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 | Approximately 4 weeks | Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16. |
Secondary
| Measure | Time frame |
|---|---|
| The number of adverse events | Approximately 4 weeks |
Countries
United States
Outcome results
None listed