Viral Mucosal Reprogramming

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Apr 8, 2022

Keywords

ClinConnect Summary

This clinical trial, called "Viral Mucosal Reprogramming," is studying the effects of a treatment known as RG-RV16 on people with asthma, allergic rhinitis (a condition causing sneezing and a runny nose), cat allergies, and healthy individuals. The researchers aim to understand how this treatment affects the genes in the airways and any changes in airway structure. The trial will include 75 participants divided into three groups: 25 healthy individuals, 25 people with allergic rhinitis due to cat dander, and 25 individuals with allergic asthma also linked to cat dander. To be eligible, participants must be between 18 and 60 years old, have no significant respiratory diseases, and meet specific allergy criteria related to cats.

Participants can expect to undergo several initial tests, including breathing tests and blood samples, to confirm their eligibility before receiving the treatment. The study is currently recruiting and aims to ensure safety by excluding those who have certain medical conditions or are taking specific medications. If you or someone you know fits the criteria and is interested in participating, this trial may provide valuable insights into new treatment options for allergy and asthma conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy Normal Control Group
• • 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.
• • Allergic Rhinitis Group
• • 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.
• • Allergic Asthma Group
• • Inclusion 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 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
• Exclusion Criteria:
• • Healthy Group Normal Group
• • 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).
• • Allergic Rhinitis Group
• • 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
• • Allergic Asthma Group
• • 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