Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT05331170

Viral Mucosal Reprogramming

Led by The University of Texas Medical Branch, Galveston · Updated on 2025-01-28

75

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Medical Branch, Galveston

Lead Sponsor

N

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Viral Mucosal Reprogramming

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and provide informed consent
  • Age between 18 and 60 years inclusive
  • Male or Female

Healthy Normal Control Group:

  • No history of asthma, COPD, rhinitis, or other significant respiratory diseases
  • Non-smoker or ex-smoker with less than 10 pack years, quit at least 5 years ago
  • No history of diabetes or cardiovascular disease
  • Negative ImmunoCAP test or documented negative skin test or specific IgE for relevant allergens within past 12 months

Allergic Rhinitis Group:

  • History of physician-diagnosed rhinitis with seasonal or perennial nasal congestion, sneezing, or conjunctival infection
  • No history of asthma, COPD, or other significant respiratory diseases
  • Non-smoker or ex-smoker with less than 10 pack years, quit at least 5 years ago
  • No history of diabetes or cardiovascular disease
  • Positive ImmunoCAP test to cat dander or documented positive skin test or specific IgE
  • Regular exposure to cat dander via home environment
  • No evidence of airway obstruction on spirometry

Allergic Asthma Group:

  • History of physician-diagnosed mild to moderate asthma
  • No history of COPD or other significant respiratory diseases besides asthma
  • Non-smoker or ex-smoker with less than 10 pack years, quit at least 5 years ago
  • No history of diabetes or cardiovascular disease
  • Airway obstruction reversible with albuterol or requiring inhaled corticosteroids for asthma control within past 12 months
  • Positive ImmunoCAP test to cat dander or documented positive skin test or specific IgE
  • Regular exposure to cat dander
  • Normal complete blood count without clinically important abnormalities
Not Eligible

You will not qualify if you...

Healthy Group:

  • Unable or unwilling to comply with study protocol
  • Currently taking inhaled corticosteroids, leukotriene modifiers, or antihistamines for respiratory disease
  • Neutralizing antibody to RV16 ≥ 1:8
  • Pregnant, breastfeeding, or planning pregnancy during study
  • Household contacts who are pregnant, have chronic respiratory disease, are children under 2 years, adults over 60 years, or immunosuppressed
  • Providing healthcare services or working with elderly or children

Allergic Rhinitis Group:

  • Unable or unwilling to comply with study protocol
  • Currently using inhaled steroids or oral montelukast
  • Neutralizing antibody to RV16 ≥ 1:8
  • Pregnant, breastfeeding, or planning pregnancy during study
  • Household contacts as above
  • Providing healthcare services or working with elderly or children
  • Immunosuppressive treatment within past 12 months
  • BMI over 35
  • Symptoms of viral upper respiratory infection within past 21 days
  • Abnormal complete blood count
  • Family or personal history of liver disease or bleeding disorders
  • No systemic corticosteroids within 3 months before screening
  • Use of antiplatelet agents other than aspirin
  • Positive COVID-19 test within past 8 weeks

Allergic Asthma Group:

  • Unable or unwilling to comply with study protocol
  • Taking respiratory medications other than ICS, montelukast, rescue albuterol, or LABAs
  • Neutralizing antibody to RV16 ≥ 1:8
  • FEV1:FVC ratio less than 0.6 or FEV1 less than 60% predicted
  • Recent asthma exacerbation requiring systemic corticosteroids within 30 days
  • ICS dose greater than fluticasone 500 mcg/day or equivalent
  • Pregnant, breastfeeding, or planning pregnancy during study
  • Household contacts as above
  • Providing healthcare services or working with elderly or children
  • Immunosuppressive treatment within past 12 months
  • BMI over 35
  • Symptoms of viral upper respiratory infection within past 21 days
  • Family or personal history of liver disease or bleeding disorders
  • No systemic corticosteroids within 3 months before screening
  • ACT score over 19 at enrollment
  • Use of antiplatelet agents other than aspirin
  • Positive COVID-19 test within past 8 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Actively Recruiting

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Research Team

L

Lisa Sweeney, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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