Viral Mucosal Reprogramming
Eligible age
18–60 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: The University of Texas Medical Branch, Galveston
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Galveston
Source: ClinicalTrials.gov · NCT05331170 · last updated 2025-01-28