NCT05331170

Viral Mucosal Reprogramming

Epigenetic Mechanism Reprogramming Mucosal Anti-viral Immunity in Allergic Asthma VIRAL MUCOSAL REPROGRAMMING

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma
• Allergic Rhinitis
• Cat Allergy
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Research Grade RG-RV	Exploration of the effects of RV inoculation on human airway mucosal programming in vivo

Timeline

• Start date: 2023-04-27
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2022-04-15
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study