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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Subject must be able to understand and provide informed consent
Exclusion criteria
✕. Inability or unwillingness of a participant to comply with study protocol
✕. Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease.
What they're measuring
1
ZEB-1 Expression
Timeframe: Immediate
2
Type III Interferon
Timeframe: Immediate
3
PD-L1 Expression
Timeframe: Immediate
4
RV16 Viral Titer
Timeframe: 48 hours after inoculation
Trial details
NCT IDNCT05331170
SponsorThe University of Texas Medical Branch, Galveston
✕. 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).
✕. Inability or unwillingness of a participant to comply with study protocol
✕. Currently using inhaled steroids, or oral montelukast for respiratory disease