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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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HRV-16 (100 TCID50)

Group Type EXPERIMENTAL

HRV-16 (100 TCID50)

Intervention Type 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)

Group Type EXPERIMENTAL

HRV-16 (1000 TCID50)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes