Viral Mucosal Reprogramming

NCT05331170 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: U01-UWM-0119-0240
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Asthma; Allergy; Allergic; Rhinitis; Airway; Cat dander; Respiratory

Outcome Measures

Primary Outcomes (4)

• ZEB-1 Expression

  Q-PCR

  Immediate

• Type III Interferon

  Q-RT-PCR

  Immediate

• PD-L1 Expression

  Q-RT-PCR

  Immediate

• RV16 Viral Titer

  Plaque Assays

  48 hours after inoculation

Secondary Outcomes (3)

• CD8 T cells in bronchoalveolar lavage fluid

  Immediate and 48hrs post RV16 inoculation

• Airway Remodeling

  Immediate and 48 hrs post RV16 inoculation

• URI Cold Symptoms

  Immediate and up to 7 days following inoculation

Study Arms (3)

Healthy

ACTIVE COMPARATOR

Subjects without asthma, COPD, rhinitis and with negative allergen test

Biological: Research Grade RG-RV

Allergic Rhinitis

ACTIVE COMPARATOR

Subjects without asthma, COPD and with positive allergen test

Biological: Research Grade RG-RV

Allergic Ashthma

ACTIVE COMPARATOR

Subjects with asthma and positive allergen test

Biological: Research Grade RG-RV

Interventions

Research Grade RG-RV BIOLOGICAL

Exploration of the effects of RV inoculation on human airway mucosal programming in vivo

Allergic Ashthma; Allergic Rhinitis; Healthy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic; Hypersensitivity; Rhinitis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections

Study Officials

• William J. Calhoun, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Sweeney, RN

CONTACT

409-747-5871; lanemeth@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: April 27, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)