Epigenetic Mechanism Reprogramming Mucosal Anti-viral Immunity in Allergic Asthma VIRAL MUCOSAL REPROGRAMMING
The University of Texas Medical Branch, Galveston
Summary
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- BiologicalResearch Grade RG-RV
Exploration of the effects of RV inoculation on human airway mucosal programming in vivo
Location
- University of Texas Medical BranchGalveston, Texas