Viral Mucosal Reprogramming
Recruiting now · Phase 2
Conditions studied: Asthma, Allergic Rhinitis, Cat Allergy, Healthy
In brief
This is a mechanistic, controlled, open-label, single-site study to evaluate the effects of RG-RV16 inoculation on airway mucosal gene expression and airway remodeling in 25 healthy controls (HC), in 25 allergic rhinitis subjects (AR) with cat dander allergy, and in 25 allergic asthmatic subjects (AA) with cat dander allergy. Three groups (HC, AR, and AA) will undergo screening to establish clinical history, will undergo pulmonary function testing (spirometry), and will have blood drawn for clinical characterization (IgE, , ImmunoCAP, CBC and differential), and for assessing the presence of existing neutralizing antibody against RV16. Only those who meet criteria will be permitted to continue into the interventional and run-out phases of the study.
Key facts
- Study ID
- NCT05331170
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 75
- Starts
- 2023-04-27
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2025-01-28
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Texas Medical Branch — Galveston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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