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Investigating Lung Immune Response and Microbiome Changes After Tuberculosis Exposure An Observational Study by University of Oxford
Led by University of Oxford · Updated on 2025-01-22
50
Participants Needed
3
Research Sites
215 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
U
University College, London
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the early immune response in the lungs and the respiratory microbiome after recent exposure to Mycobacterium tuberculosis (M.tb), the bacteria that causes tuberculosis (TB). This research aims to understand why some people develop protection against TB while others do not. The study focuses on the innate immune system's role, which acts before symptoms appear, and how the microbiome—the bacteria living in the airways—may influence this protection. Participants who have recently been in close contact with someone with active TB will provide sputum and blood samples. These samples will be used to examine immune cells in the lungs and blood over time and analyze the types of bacteria living in the airways. The study will compare these immune and microbiome responses to see how they might work together to protect against TB infection. During the study, participants will be monitored at the start and again after 84 days to measure changes in their immune response. Researchers will review medical history, blood tests, and imaging results to better understand each person's immune activity and microbiome changes. This will help identify differences in how people respond to TB exposure and could guide new vaccine and treatment development. The total study period includes enrollment and follow-up over about three months.
CONDITIONS
Official Title
Lung Innate Immunity and Microbiome After Tuberculosis Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years
- Resident in or near London or Oxford for the duration of the study period
- Provide written informed consent
- Willing to allow investigators to review NHS care records, medical history, blood results, and radiographs
- Able and willing to comply with all study requirements
- Have undergone TB screening through NHS services (including IGRA testing and chest X-ray if indicated)
- Close contact with a sputum smear positive TB case within the last 12 weeks
You will not qualify if you...
- Participation in another research study involving an investigational product in the 30 days before or during this study
- History of anaphylaxis or allergies likely to be worsened by study procedures
- Poorly controlled airways disease, current cancer (except certain skin or cervical conditions), bleeding disorders, or drug/alcohol abuse
- Significant autoimmune conditions or immunodeficiency, including HIV
- Previous diagnosis or treatment for active or latent TB
- Evidence of current active TB disease clinically, radiologically, or by lab tests
- Previous receipt of investigational TB vaccines or aerosolised BCG
- Significant abnormalities in lung function tests
- Use of oral, inhaled, or systemic steroids for more than 14 days in the last 6 months or other immunosuppressive agents
- Use of antibiotics in the past 4 weeks
- Receipt of immunoglobulins or blood products within 3 months before the study
- Receipt of live vaccines within 28 days or non-live vaccines within 14 days before enrollment
- Pregnancy or intention to become pregnant during the study
- Other significant diseases or conditions that may affect safety or study participation
- For Group C: history of close contact with a TB case or previous contact tracing by TB services
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Actively Recruiting
2
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxon, United Kingdom, OX3 9DZ
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3
Grove Building, Royal Free NHS Foundation Trust
London, United Kingdom, NW3 2QG
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Research Team
T
Timothy Fredsgaard-Jones, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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