Viral Mucosal Reprogramming

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT05331170
Phase
PHASE2
Status
Recruiting
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Conditions

  • Allergic Rhinitis
  • Asthma
  • Cat Allergy
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Research Grade RG-RV — BIOLOGICAL
    Exploration of the effects of RV inoculation on human airway mucosal programming in vivo

Study Details

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.

Key Dates

Start date
Apr 27, 2023
Status verified
Jan 2025
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Healthy
    Subjects without asthma, COPD, rhinitis and with negative allergen test
  • Active Comparator: Allergic Rhinitis
    Subjects without asthma, COPD and with positive allergen test
  • Active Comparator: Allergic Ashthma
    Subjects with asthma and positive allergen test

Primary Outcome Measure

ZEB-1 Expression [ Time Frame: Immediate ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical BranchGalvestonTexas77555
Lisa Sweeney, RN
[email protected]
409-747-5871
Cindy Mitchell, CCRC
[email protected]
409-772-5508
William J. Calhoun, M.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Galveston, TX

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By specialty
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By research site
University of Texas Medical Branch· Galveston, TX

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