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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014