A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: RG-HRV16; Placebo
Intervention description: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin; The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: normal

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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).

          3. Absence of HRV16 neutralizing antibody.

          4. 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.

          5. 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.

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. Subjects who provide healthcare services or work with elderly or children (e.g.
             daycare provider, senior citizen care giver).

          4. Subjects with seasonal allergies will be excluded only if allergy symptoms are present
             at baseline, or are anticipated to occur during the study period.

          5. Smoking within the past 6 months.

          6. Subjects who have received immunosuppressive treatment within the last 12 months.

          7. Upper respiratory infection (URI or sinusitis) in the past 4 weeks.

          8. Subjects with a history of a significant adverse reaction or intolerance to a previous
             live, attenuated vaccine.

          9. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the
             course of the study.

         10. 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).