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CompletedNCT01466738Updated Feb 22, 2012

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

A Phase 1 interventional study of HRV-16 (100 TCID50) and HRV-16 (1000 TCID50) in Healthy, sponsored by Centocor Ortho Biotech Services, L.L.C.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Centocor Ortho Biotech Services, L.L.C. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteer
  • Rhinovirus
  • Cold virus
  • HRV-16
03

In context

Lead sponsor

Centocor Ortho Biotech Services, L.L.C. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    HRV-16 (100 TCID50)

    Biological: HRV-16 (100 TCID50)

  • Experimental
    HRV-16 (1000 TCID50)

    Biological: HRV-16 (1000 TCID50)

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 days

  2. Serological Response

    Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.

    Time frame: Approximately 4 weeks

Secondary outcomes

  1. The number of adverse events

    Time frame: Approximately 4 weeks

07

Study locations

1 site
  • Charlottesville, Virginia, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01466738
Lead sponsor
Centocor Ortho Biotech Services, L.L.C.
First posted
Nov 8, 2011
Start date
Sep 2011
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Feb 22, 2012

Study contacts

Centocor Ortho Biotech Services, L.L.C. Clinical Trial
study director · Centocor Ortho Biotech Services, L.L.C.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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