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Virus Therapy

RG-RV for Cat Allergy (VMR Trial)

Phase 2
Recruiting
Led By William J. Calhoun, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 18-60 inclusive
No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
Must not have
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, BMI is greater than 35, History of symptoms consistent with a viral URI within the past 21 days, Results of the CBC do not show clinically important abnormalities, Family history or medical history of liver disease or bleeding disorders, Have not received systemic corticosteroids for 3months prior to Screening, Antiplatelet agents other than aspirin, Subjects who have a positive COVID-19 test will be excluded for 8 weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate and 48hrs post rv16 inoculation
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the effects of an inoculation on airway gene expression and remodeling in people with/without allergies to cat dander. Screening, blood draws, and pulmonary testing will be done to determine eligibility.

Who is the study for?
This trial is for healthy adults, allergic rhinitis sufferers, and mild-moderate asthmatics aged 18-60 with cat dander allergy. Participants must be non-smokers or long-term ex-smokers without serious respiratory diseases, diabetes, cardiovascular disease, or immune system issues. Pregnant women and those unable to follow the protocol are excluded.
What is being tested?
The study tests RG-RV16's impact on airway genes and remodeling in three groups: healthy individuals (HC), people with allergic rhinitis (AR), and asthmatics (AA) - all sensitive to cat dander. It involves clinical history review, lung function tests, blood work for allergies and antibodies against RV16.
What are the potential side effects?
Potential side effects aren't specified but may include typical responses to inoculations such as local reactions at the injection site, flu-like symptoms or exacerbation of asthma/allergy symptoms due to immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.
Select...
I have no history of asthma, COPD, or significant respiratory issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PD-L1 Expression
RV16 Viral Titer
Type III Interferon
+1 more
Secondary study objectives
Airway Remodeling
CD8 T cells in bronchoalveolar lavage fluid
URI Cold Symptoms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: HealthyActive Control1 Intervention
Subjects without asthma, COPD, rhinitis and with negative allergen test
Group II: Allergic RhinitisActive Control1 Intervention
Subjects without asthma, COPD and with positive allergen test
Group III: Allergic AshthmaActive Control1 Intervention
Subjects with asthma and positive allergen test

Find a Location

Who is running the clinical trial?

Mohammad Zaidan, MDUNKNOWN
The University of Texas Medical Branch, GalvestonLead Sponsor
252 Previous Clinical Trials
56,811 Total Patients Enrolled
3 Trials studying Asthma
146 Patients Enrolled for Asthma
William J. Calhoun, MDPrincipal InvestigatorUniversity of Texas
4 Previous Clinical Trials
651 Total Patients Enrolled
3 Trials studying Asthma
644 Patients Enrolled for Asthma

Media Library

Research Grade RG-RV (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05331170 — Phase 2
Asthma Research Study Groups: Healthy, Allergic Rhinitis, Allergic Ashthma
Asthma Clinical Trial 2023: Research Grade RG-RV Highlights & Side Effects. Trial Name: NCT05331170 — Phase 2
Research Grade RG-RV (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05331170 — Phase 2
Asthma Patient Testimony for trial: Trial Name: NCT05331170 — Phase 2
~45 spots leftby May 2027
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