Viral Mucosal Reprogramming

Eligibility Criteria

• 1. Subject must be able to understand and provide informed consent
• 2. Age: 18-60 inclusive
• 3. Sex: M or F
• 4. No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
• 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote.
• 6. No history of diabetes or cardiovascular disease
• 7. Negative ImmunoCAP test to regionally relevant allergen panel obtained at Screening. Alternatively, documented history of a negative skin test or negative specific IgE obtained within the past 12 months.
• 1. Subject must be able to understand and provide informed consent
• 2. Age: 18-60 inclusive
• 3. Sex: M or F
• 4. No history of asthma, COPD, or other clinically important respiratory disease
• 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
• 6. No history of diabetes or cardiovascular disease
• 7. History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months
• 8. Seasonal or perennial nasal congestion or sneezing
• 9. Seasonal or perennial conjunctival infection or watering
• 10. No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal)
• 11. Positive ImmunoCAP test to cat. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criterion. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months.
• 1. Subject must be able to understand and provide informed consent
• 2. Age: 18-60 inclusive
• 3. Sex: M or F
• 4. No history of COPD or other clinically important respiratory disease other than asthma
• 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
• 6. No history of diabetes or cardiovascular disease
• 7. History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months
• 1. Airway obstruction (FEV1: FVC \<0.6) that is significantly (at least 12% change from baseline, ATS criteria) reversible after 4 puffs of albuterol (obtained at Screening Visit or documented historical testing performed with the past 12 months)
• 2. Requiring ICS for control of asthma for at least 30 days within the past 12 months
• 8. Positive ImmunoCAP test to cat dander. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criteria. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months.
• 9. Results of the CBC do not show clinically important abnormalities
• 1. Inability or unwillingness of a participant to comply with study protocol
• 2. Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease.
• 3. Neutralizing Ab to RV16 greater than or equal to 1:8
• 4. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at the screening visit. Pregnancy testing may be conducted prior to procedures as well at various times in the study.
• 5. Subjects with household or close 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 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV).
• 6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
• 1. Inability or unwillingness of a participant to comply with study protocol
• 2. Currently using inhaled steroids, or oral montelukast for respiratory disease
• 3. Neutralizing Ab to RV16 greater than or equal to 1:8
• 4. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening visit. Pregnancy testing may be conducted prior to procedures as well at various times in the study.
• 5. Subjects with household or close 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 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV) .
• 6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
• 7. Subjects who have received immunosuppressive treatment within the last 12 months
• 8. BMI is greater than 35
• 9. History of symptoms consistent with a viral URI within the past 21 days
• 10. Results of the CBC do not show clinically important abnormalities
• 11. Family history or medical history of liver disease or bleeding disorders
• 12. Have not received systemic corticosteroids for 3months prior to Screening
• 13. Antiplatelet agents other than aspirin
• 14. Subjects who have a positive COVID-19 test will be excluded for 8 weeks
• 1. Inability or unwillingness of a participant to comply with study protocol
• 2. Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs.
• 3. Neutralizing Ab to RV16 greater than or equal to 1:8
• 4. FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted
• 5. Recent (\<30 days) exacerbation of asthma requiring systemic corticosteroids
• 6. ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening.
• 7. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening. Pregnancy testing may be conducted prior to procedures as well at various times in the study.
• 8. Subjects with household or close 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 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV) .
• 9. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
• 10. Subjects who have received immunosuppressive treatment within the last 12 months
• 11. BMI is greater than 35
• 12. History of symptoms consistent with a viral URI within the past 21 days
• 13. Family history or medical history of liver disease or bleeding disorders
• 14. Have not received systemic corticosteroids for 3 months prior to Screening
• 15. Have an ACT score \>19 at the time of enrollment.
• 16. Antiplatelet agents other than aspirin
• 17. Subjects who have a positive COVID-19 test will be excluded for 8 weeks