Viral Mucosal Reprogramming

Inclusion criteria

Healthy Normal Control Group

• Subject must be able to understand and provide informed consent
• Age: 18-60 inclusive
• Sex: M or F
• No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
• Non-smoker, or ex-smoker with <10 pack years, at least 5 years remote.
• No history of diabetes or cardiovascular disease
• 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.

Allergic Rhinitis Group

• Subject must be able to understand and provide informed consent
• Age: 18-60 inclusive
• Sex: M or F
• No history of asthma, COPD, or other clinically important respiratory disease
• Non-smoker, or ex-smoker with <10 pack years, at least 5 years remote
• No history of diabetes or cardiovascular disease
• History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months
• Seasonal or perennial nasal congestion or sneezing
• Seasonal or perennial conjunctival infection or watering
• No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal)
• 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.

Allergic Asthma Group

Inclusion criteria

• Subject must be able to understand and provide informed consent
• Age: 18-60 inclusive
• Sex: M or F
• No history of COPD or other clinically important respiratory disease other than asthma
• Non-smoker, or ex-smoker with <10 pack years, at least 5 years remote
• No history of diabetes or cardiovascular disease
• History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months

• 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)
• Requiring ICS for control of asthma for at least 30 days within the past 12 months
• 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.
• Results of the CBC do not show clinically important abnormalities

Exclusion criteria

Healthy Group Normal Group

• Inability or unwillingness of a participant to comply with study protocol
• Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease.
• Neutralizing Ab to RV16 greater than or equal to 1:8
• 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.
• 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).
• Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).

Allergic Rhinitis Group

• Inability or unwillingness of a participant to comply with study protocol
• Currently using inhaled steroids, or oral montelukast for respiratory disease
• Neutralizing Ab to RV16 greater than or equal to 1:8
• 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.
• 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) .
• Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
• Subjects who have received immunosuppressive treatment within the last 12 months
• BMI is greater than 35
• History of symptoms consistent with a viral URI within the past 21 days
• Results of the CBC do not show clinically important abnormalities
• Family history or medical history of liver disease or bleeding disorders
• Have not received systemic corticosteroids for 3months prior to Screening
• Antiplatelet agents other than aspirin
• Subjects who have a positive COVID-19 test will be excluded for 8 weeks

Allergic Asthma Group

• Inability or unwillingness of a participant to comply with study protocol
• Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs.
• Neutralizing Ab to RV16 greater than or equal to 1:8
• FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted
• Recent (<30 days) exacerbation of asthma requiring systemic corticosteroids
• ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening.
• 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.
• 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) .
• Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
• Subjects who have received immunosuppressive treatment within the last 12 months
• BMI is greater than 35
• History of symptoms consistent with a viral URI within the past 21 days
• Family history or medical history of liver disease or bleeding disorders
• Have not received systemic corticosteroids for 3 months prior to Screening
• Have an ACT score >19 at the time of enrollment.
• Antiplatelet agents other than aspirin
• Subjects who have a positive COVID-19 test will be excluded for 8 weeks