Actively Recruiting
Investigating the Impact of the Pulmonary Innate Immune Response and Microbiome After Exposure to Mycobacterium Tuberculosis
Led by University of Oxford · Updated on 2025-01-22
50
Participants Needed
3
Research Sites
104 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 investigating 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 study aims to understand how variations in the body's initial immune defense and the community of bacteria in the airways affect whether someone develops TB. The findings could help develop better vaccines and treatments for TB, a leading cause of infectious disease deaths worldwide. The study involves three groups of adult volunteers aged 18 to 65: those recently exposed to TB with positive immune tests, those recently exposed with negative immune tests, and healthy adults without prior TB exposure. Researchers will collect sputum and blood samples at enrollment and after 84 days to analyze innate immune cells and the diversity of bacteria in the airways. This observational study does not involve any treatments but focuses on monitoring immune and microbiome changes over time. Participants will provide consent and allow access to their medical records and previous test results. They will undergo sample collection for immune cell and microbiome analysis at two time points. The main outcomes measured include changes in immune cells in blood and sputum, and differences in airway bacterial diversity between exposed and healthy individuals. The study will last at least 84 days with careful monitoring to understand the body's early defense against TB after exposure.
CONDITIONS
Brief 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 study duration
- Able to provide written informed consent
- Willing to allow review of NHS care records, medical history, blood results, and radiographs
- Able and willing to comply with all study requirements
- For groups A and B: have undergone TB screening via NHS services
- For groups A and B: recent 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 investigational products within 30 days before enrollment or during follow-up
- History of anaphylaxis or allergies likely worsened by study procedures
- Poorly controlled airways disease, current cancer (except certain skin or cervical conditions), bleeding disorder, or substance abuse
- Significant autoimmune conditions or immunodeficiency including HIV
- Previous diagnosis or treatment for active or latent TB
- Evidence of current active TB disease
- Previous receipt of investigational TB vaccines or aerosolised BCG
- Significant abnormalities in lung function tests
- Use of oral, inhaled, or systemic steroids or other immunosuppressants recently
- Antibiotic use within the past 4 weeks
- Recent administration of immunoglobulins, blood products, or vaccines
- Pregnancy or intention to become pregnant during the study
- Any condition that may risk safety or affect participation or data interpretation
- For group C: history of TB contact or previous TB contact tracing by services
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants provide sputum and blood samples at enrollment and on Day 84 to study early immune responses and airway microbiome changes after exposure to Mycobacterium tuberculosis.
2 visits (in-person)
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
Actively Recruiting
3
Grove Building, Royal Free NHS Foundation Trust
London, United Kingdom, NW3 2QG
Actively Recruiting
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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