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Viral Mucosal Reprogramming

Study acronym: VMR
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Collaborators expanded, about 8 wordsv7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2023 to Apr 27, 2023
    • Collaborators shortened, about 3 words
    v6
  3. Start date: Sep 1, 2022 to Apr 1, 2023v5
  4. Start date: Jul 1, 2022 to Sep 1, 2022v4
  5. Start date: May 1, 2022 to Jul 1, 2022v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05331170
Lead Sponsor The University of Texas Medical Branch, Galveston
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Asthma, Allergic Rhinitis, Cat Allergy, Healthy
Related terms Asthma, Hypersensitivity, Rhinitis, Rhinitis, Allergic
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov