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.