A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

This research study will test different doses of RG-HRV16 to find the minimum dose needed to give research subjects cold symptoms of at least moderate intensity. The study will also test the safety of RG-HRV16. This information will be used in future studies (for example, to test antiviral preparations, sprays that could protect from getting a cold or decrease cold symptoms or to understand more about how rhinovirus can lead to asthma worsening). RG-HRV16 is a common cold virus that has been made in a new way and has not been used in humans before.

Key facts

Study ID

NCT01769573

Run by

University of Wisconsin, Madison

People needed

36

Starts

2013-07-01

Expected to finish

2017-12-01

Last updated by the study team

2019-06-03

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Capable and willing to grant written informed consent (in English) and cooperate with study procedures and requirements including willingness to avoid cold symptom medications during the study.
• Age between 18 and 50 years (children and older adults will be excluded from the study due to the possibility of greater morbidity associated with upper respiratory infections in these age groups).
• Absence of HRV16 neutralizing antibody.
• Safety laboratory assessments within normal University of WI Hospital and Clinics (UWHC) ranges or grade 1 (mild) laboratory abnormalities which are deemed not clinically significant in the judgment of the PI. Labs to include CBC with differential and platelets, BUN, creatinine, AST, ALT and IgA and IgG serum immunoglobulins. Any lymphopenia outside of the normal range will be an absolute exclusion.
• Subjects must be willing to refrain from taking nasal decongestants, antihistamines or cough/cold preparations (this includes dietary supplements and homeopathic preparations used specifically for cold/flu e.g., vitamin C, zinc, echinacea) within the 7 days prior to Visit 1 and throughout the study until after the completion of Visit 5.

You may not qualify if…

• A chronic medical condition, which may increase risk or interfere with the conduct of the study, including, but not limited to heart disease, Type I of II diabetes mellitus, asthma, COPD, other chronic lung disease, perennial rhinitis and chronic rhinosinusitis.
• Subjects with household contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 50 years of age.
• Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
• Subjects with seasonal allergies will be excluded only if allergy symptoms are present at baseline, or are anticipated to occur during the study period.
• Smoking within the past 6 months.
• Subjects who have received immunosuppressive treatment within the last 12 months.
• Upper respiratory infection (URI or sinusitis) in the past 4 weeks.
• Subjects with a history of a significant adverse reaction or intolerance to a previous live, attenuated vaccine.
• Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study.
• Unwillingness of study participants to use adequate birth control methods during the course of the study. Adequate birth control methods include oral contraceptives, injections such as Depo-Provera, an intrauterine device or double-barrier contraception (combination of condom and contraceptive sponge or cervical cap and spermicide or another combination approved in writing by the Principal Investigator).

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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