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AsthmaPhase 2VMRNCT05331170

Viral Mucosal Reprogramming

A Phase 2 study testing Research Grade RG-RV in people with Asthma and Allergic Rhinitis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Asthma, Allergic Rhinitis, Cat Allergy
What is being tested?
Research Grade RG-RV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
27 Apr 2023to 1 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy Normal Control Group
  • Subject must be able to understand and provide informed consent
  • Age: 18-60 inclusive
  • Sex: M or F
  • No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
  • Non-smoker, or ex-smoker with <10 pack years, at least 5 years remote.
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  • No history of diabetes or cardiovascular disease
  • Negative ImmunoCAP test to regionally relevant allergen panel obtained at Screening. Alternatively, documented history of a negative skin test or negative specific IgE obtained within the past 12 months.
  • Allergic Rhinitis Group
  • Subject must be able to understand and provide informed consent
  • Age: 18-60 inclusive
  • Sex: M or F
  • No history of asthma, COPD, or other clinically important respiratory disease
  • Non-smoker, or ex-smoker with <10 pack years, at least 5 years remote
  • No history of diabetes or cardiovascular disease
  • History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months
  • Seasonal or perennial nasal congestion or sneezing
  • Seasonal or perennial conjunctival infection or watering
  • No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal)
  • Positive ImmunoCAP test to cat. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criterion. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months.
  • Allergic Asthma Group
  • Subject must be able to understand and provide informed consent
  • Age: 18-60 inclusive
  • Sex: M or F
  • No history of COPD or other clinically important respiratory disease other than asthma
  • Non-smoker, or ex-smoker with <10 pack years, at least 5 years remote
  • No history of diabetes or cardiovascular disease
  • History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months
  • Airway obstruction (FEV1: FVC <0.6) that is significantly (at least 12% change from baseline, ATS criteria) reversible after 4 puffs of albuterol (obtained at Screening Visit or documented historical testing performed with the past 12 months)
  • Requiring ICS for control of asthma for at least 30 days within the past 12 months
  • Positive ImmunoCAP test to cat dander. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criteria. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months.
  • Results of the CBC do not show clinically important abnormalities

Who cannot join

  • Healthy Group Normal Group
  • Inability or unwillingness of a participant to comply with study protocol
  • Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines 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 the 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).
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  • Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
  • 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
  • Allergic Asthma Group
  • Inability or unwillingness of a participant to comply with study protocol
  • Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs.
  • Neutralizing Ab to RV16 greater than or equal to 1:8
  • FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted
  • Recent (<30 days) exacerbation of asthma requiring systemic corticosteroids
  • ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening.
  • 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. 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
  • Family history or medical history of liver disease or bleeding disorders
  • Have not received systemic corticosteroids for 3 months prior to Screening
  • Have an ACT score >19 at the time of enrollment.
  • Antiplatelet agents other than aspirin
  • Subjects who have a positive COVID-19 test will be excluded for 8 weeks

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Sweeney, RN contact

409-747-5871

lanemeth@utmb.edu

United States1 site, 1 recruiting

  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Lisa Sweeney, RN, 409-747-5871, lanemeth@utmb.edu

    Cindy Mitchell, CCRC, 409-772-5508, cimitche@utmb.edu

    Recruiting

Other trials in United States

About this study

Official title: Epigenetic Mechanism Reprogramming Mucosal Anti-viral Immunity in Allergic Asthma VIRAL MUCOSAL REPROGRAMMING

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.

Being tested
Research Grade RG-RV
Keywords
Asthma, Allergy, Allergic, Rhinitis, Airway, Cat dander, Respiratory
Medical subject headings
Asthma, Rhinitis, Allergic, Hypersensitivity, Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Research Grade RG-RVBiological

    Exploration of the effects of RV inoculation on human airway mucosal programming in vivo

Study groups in NCT05331170
Study groupRoleWhat they receive
HealthyActive comparatorSubjects without asthma, COPD, rhinitis and with negative allergen test
Receives: Biological: Research Grade RG-RV
Allergic RhinitisActive comparatorSubjects without asthma, COPD and with positive allergen test
Receives: Biological: Research Grade RG-RV
Allergic AshthmaActive comparatorSubjects with asthma and positive allergen test
Receives: Biological: Research Grade RG-RV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ZEB-1 Expression

    Q-PCR

    Measured: Immediate

  2. Type III Interferon

    Q-RT-PCR

    Measured: Immediate

  3. PD-L1 Expression

    Q-RT-PCR

    Measured: Immediate

  4. RV16 Viral Titer

    Plaque Assays

    Measured: 48 hours after inoculation

Secondary outcomes (3)

  1. CD8 T cells in bronchoalveolar lavage fluid

    Proportion and number of CD8+ T cells

    Measured: Immediate and 48hrs post RV16 inoculation

  2. Airway Remodeling

    Lamina reticularis thickness

    Measured: Immediate and 48 hrs post RV16 inoculation

  3. URI Cold Symptoms

    WURSS21 Questionnaire

    Measured: Immediate and up to 7 days following inoculation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start27 Apr 2023
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05331170
Sponsor's protocol ID
U01-UWM-01
Other IDs
19-0240
Acronym
VMR
Status last verified
Jan 2025
First submitted
8 Apr 2022
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Research Grade RG-RV in people with Asthma and Allergic Rhinitis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Sweeney, RN (409-747-5871, lanemeth@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ZEB-1 Expression (time frame: Immediate). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05331170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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