Study of Airway Inflammatory Responses to Experimental Rhinovirus Infection

16-3283

This study is designed to characterize in detail the clinical, physiologic, and inflammatory features of Human Rhinovirus (HRV) infection in healthy volunteers without underlying lung disease while also evaluating the safety of HRV administrations.

2024-03-01

2026-06-01

2026-07-01

Early phase I

23

Inclusion Criteria: 1. Age 18-45 years of either gender 2. Non-smoker (less than 10 cigarettes per month for at least the prior 3 years) 3. Negative pregnancy test (for females as applicable) 4. Oxygen saturation of \> 94% and blood pressure with systolic value between 140-90 mm Hg and diastolic between 80-55 mm Hg 5. Willingness to hold all nasal medications (including, but not limited to, nasal steroids or nasal spray decongestants), oral antihistamines and leukotriene inhibitors for at least 1 week prior to Day 0 and continuing throughout the remaining study period. 6. Negative Allergy Skin Test (AST) at a separate screening visit performed prior to study enrollment, University of North Carolina Institutional Review Board (UNC IRB) approved study # 98-0799, Database and Screening Protocol for Research Studies of the Center for Environmental Medicine and Lung Biology (CEMALB). (Results from AST performed within the past 12 months as part of another study protocol or AST reports from testing performed by the subject's Medical Doctor (MD) within the past 12 months will also be accepted.) 7. Negative methacholine inhalation challenge as performed in the separate screening protocol. (Less than a 20% decrease in Forced Exhaled Volume at 1 second (FEV1) at a maximum methacholine concentration of 10 mg/ml). 8. Normal lung function, defined as (NHANES III predicted set): * Forced Vital Capacity (FVC) of ≥ 80 % of that predicted for gender, ethnicity, age and height * FEV1 of ≥ 80 % of that predicted for gender, ethnicity, age and height * Ratio of Forced Exhaled Volume at 1 second to Forced Vital Capacity (FEV1/FVC) ≥ .75 9. No nasal symptoms, based on respiratory questionnaire Exclusion Criteria: 1. Presence of neutralizing antibodies to RG-HRV-16 at the screening visit to a titer of ≥ 1:2. 2. Inability or unwillingness of a participant to give written informed consent 3. History of rhinitis, chronic sinusitis, or other sinus disease, or any chronic cardiorespiratory disease 4. Subjects with household contacts with chronic lung disease, who are children under the age of 2 years, and who are adults over the age of 65 years 5. Subjects who live in communal settings (i.e. dormitories) 6. Respiratory infection (cough, sore throat, sinusitis, fever etc) within prior 4 weeks 7. Received any live vaccine in the past 4 weeks or an inactivated vaccine within the past 2 weeks 8. Active wheezing at the time of the Day 0 visit 9. Pregnancy or nursing or women who are currently trying to become pregnant; all female subjects, except those who have had a hysterectomy with oophorectomy, will undergo urine pregnancy testing on the morning of the screening visit and again on the on Day 0 at the time of arrival to the lab and prior to HRV administration. A positive pregnancy test will exclude the subject 10. History of any immunosuppressive disease or a positive Human immunodeficiency virus (HIV) test at the screening visit 11. Use of immunosuppressive drugs within the past 6 months 12. Chronic medications which, in the opinion of the study physician(s), may either increase the risks of participation or may interfere with the findings of the study 13. Current use of beta-adrenergic blocking agents 14. Current use of antidepressants if classified as tricyclic or Monoamine oxidase inhibitors (MAO) inhibitors; 15. Known hypersensitivity to methacholine or to other parasympathomimetic agents; 16. History of fainting or feeling severely dizzy with blood draws 17. History of Guillain-Barre syndrome 18. Subjects who will be unable to avoid contact with immunocompromised individuals for 3 weeks after receiving RG-HRV16 19. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study; 20. Unwillingness to use reliable contraception if sexually active (Intrauterine Device (IUD), birth control pills/patch, condoms) 21. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements 22. Participation in any study using an investigational agent within 30 days of enrollment.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ESTIMATED'}}

2023-08-02