A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by:
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT01466738
First received: November 4, 2011
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: HRV-16 (100 TCID50)
Biological: HRV-16 (1000 TCID50)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Clinical Characterization of a Human Rhinovirus Type 16 Challenge Pool Following Intranasal Administration to Healthy Adult Subjects

Further study details as provided by Centocor Ortho Biotech Services, L.L.C.:

Primary Outcome Measures:
  • Clinical symptoms to HRV-16 [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.


Secondary Outcome Measures:
  • The number of adverse events [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HRV-16 (100 TCID50) Biological: 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.
Experimental: HRV-16 (1000 TCID50) Biological: 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.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466738

Locations
United States, Virginia
Charlottesville, Virginia, United States
Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Investigators
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
  More Information

No publications provided

Responsible Party: Sr. Director, Translational Medicine, Janssen Research and Development, US
ClinicalTrials.gov Identifier: NCT01466738     History of Changes
Other Study ID Numbers: CR018733, NOCOMPOUNDASH1001
Study First Received: November 4, 2011
Last Updated: February 20, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Healthy volunteer
Rhinovirus
Cold virus
HRV-16

ClinicalTrials.gov processed this record on April 21, 2014