Viral Mucosal Reprogramming

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

Viral Mucosal Reprogramming (NCT05331170) is a Phase 2 interventional studying Asthma and Allergic Rhinitis, sponsored by The University of Texas Medical Branch, Galveston. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Asthma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 75 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Asthma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Healthy Normal Control Group 1. Subject must be able to understand and provide willing to sign a consent form 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of asthma, COPD, rhinitis, or other clinically important respiratory disease 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote. 6. No history of diabetes or cardiovascular disease 7. 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 1. Subject must be able to understand and provide willing to sign a consent form 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of asthma, COPD, or other clinically important respiratory disease 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote 6. No history of diabetes or cardiovascular disease 7. History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months 8. Seasonal or perennial nasal congestion or sneezing 9. Seasonal or perennial conjunctival infection or watering 10. No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal) 11. 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 Inclusion Criteria 1. Subject must be able to understand and provide willing to sign a consent form 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of COPD or other clinically important respiratory disease other than asthma 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote 6. No history of diabetes or cardiovascular disease ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Healthy Normal Control Group 1. Subject must be able to understand and provide informed consent 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of asthma, COPD, rhinitis, or other clinically important respiratory disease 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote. 6. No history of diabetes or cardiovascular disease 7. 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 1. Subject must be able to understand and provide informed consent 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of asthma, COPD, or other clinically important respiratory disease 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote 6. No history of diabetes or cardiovascular disease 7. History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months 8. Seasonal or perennial nasal congestion or sneezing 9. Seasonal or perennial conjunctival infection or watering 10. No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal) 11. 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 Inclusion Criteria 1. Subject must be able to understand and provide informed consent 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of COPD or other clinically important respiratory disease other than asthma 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote 6. No history of diabetes or cardiovascular disease 7. History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months 1. 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) 2. Requiring ICS for control of asthma for at least 30 days within the past 12 months 8. 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. 9. Results of the CBC do not show clinically important abnormalities Exclusion Criteria: Healthy Group Normal Group 1. Inability or unwillingness of a participant to comply with study protocol 2. Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease. 3. Neutralizing Ab to RV16 greater than or equal to 1:8 4. 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. 5. 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). 6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver). Allergic Rhinitis Group 1. Inability or unwillingness of a participant to comply with study protocol 2. Currently using inhaled steroids, or oral montelukast for respiratory disease 3. Neutralizing Ab to RV16 greater than or equal to 1:8 4. 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. 5. 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) . 6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver). 7. Subjects who have received immunosuppressive treatment within the last 12 months 8. BMI is greater than 35 9. History of symptoms consistent with a viral URI within the past 21 days 10. Results of the CBC do not show clinically important abnormalities 11. Family history or medical history of liver disease or bleeding disorders 12. Have not received systemic corticosteroids for 3months prior to Screening 13. Antiplatelet agents other than aspirin 14. Subjects who have a positive COVID-19 test will be excluded for 8 weeks Allergic Asthma Group 1. Inability or unwillingness of a participant to comply with study protocol 2. Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs. 3. Neutralizing Ab to RV16 greater than or equal to 1:8 4. FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted 5. Recent (\<30 days) exacerbation of asthma requiring systemic corticosteroids 6. ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening. 7. 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. 8. 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) . 9. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver). 10. Subjects who have received immunosuppressive treatment within the last 12 months 11. BMI is greater than 35 12. History of symptoms consistent with a viral URI within the past 21 days 13. Family history or medical history of liver disease or bleeding disorders 14. Have not received systemic corticosteroids for 3 months prior to Screening 15. Have an ACT score \>19 at the time of enrollment. 16. Antiplatelet agents other than aspirin 17. Subjects who have a positive COVID-19 test will be excluded for 8 weeks

Treatments Being Tested

BIOLOGICAL

Research Grade RG-RV

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Texas Medical Branch

Galveston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05331170), the sponsor (The University of Texas Medical Branch, Galveston), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05331170 clinical trial studying?

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 ex… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05331170?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05331170?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05331170. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05331170. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.