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

February 20, 2012 updated by: Centocor Ortho Biotech Services, L.L.C.

Clinical Characterization of a Human Rhinovirus Type 16 Challenge Pool Following Intranasal Administration to Healthy Adult Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptoms to HRV-16
Time Frame: 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.
6 days
Serological Response
Time Frame: Approximately 4 weeks
Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.
Approximately 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of adverse events
Time Frame: Approximately 4 weeks
Approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centocor Ortho Biotech Services, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR018733
  • NOCOMPOUNDASH1001 (Other Identifier: Centocor Ortho Biotech Services, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on HRV-16 (100 TCID50)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe