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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: HRV-16 (100 TCID50); Biological: HRV-16 (1000 TCID50)

• Registration Number: NCT01466738
• Lead Sponsor: Centocor Ortho Biotech Services, L.L.C.

Brief 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.

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 Timeline

• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRV-16 (100 TCID50)	HRV-16 (100 TCID50)	-
HRV-16 (1000 TCID50)	HRV-16 (1000 TCID50)	-

Primary Outcome Measures

Name	Time	Method
Clinical symptoms to HRV-16	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.
Serological Response	Approximately 4 weeks	Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.

Secondary Outcome Measures

Name	Time	Method
The number of adverse events	Approximately 4 weeks