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Completed

NCT Number: NCT01466738

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charlottesville, Virginia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRV-16 (100 TCID50)

Biological

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.

HRV-16 (1000 TCID50)

Biological

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.

Primary outcomes

  1. 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.

  2. Serological Response

    Time frame: Approximately 4 weeks

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

Secondary outcomes

  1. The number of adverse events

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Centocor Ortho Biotech Services, L.L.C.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 8, 2011
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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