Understanding lung immune responses and microbiome after tuberculosis exposure
Investigating the Impact of the Pulmonary Innate Immune Response and Microbiome After Exposure to Mycobacterium Tuberculosis
This study looks at how the lungs' immune system and bacteria change in people who have recently been around someone with tuberculosis to help improve future vaccines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 3 sites (Oxford, Oxfordshire and 2 other locations) |
| Trial ID | NCT06526689 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the innate pulmonary immune response and respiratory microbiome in individuals who have recently been exposed to Mycobacterium tuberculosis (M.tb). By analyzing sputum samples from adults who have had close contact with active TB cases, the study seeks to understand the variations in immune responses and how these differences may influence the outcome of M.tb exposure. The research focuses on the early immune response, which is crucial for developing effective vaccines against tuberculosis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have recently been in close contact with someone diagnosed with active tuberculosis.
Not a fit: Patients with poorly controlled airway diseases or those currently undergoing treatment for cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing tuberculosis infection and enhancing vaccine development.
How similar studies have performed: While the study focuses on a novel approach to understanding TB exposure, similar studies have shown promise in characterizing immune responses in other infectious diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Adults aged 18-65 years
2. Resident in or near London or Oxford for the duration of the study period
3. Provide written informed consent
4. Willing to allow the investigators to review the volunteer's review NHS care record, medical history, blood results and radiographs.
5. Able and willing (in the investigator's opinion) to comply with all study requirements
Group A and B Specific Inclusion Criteria
6. Have undergone screening for TB through NHS services (including IGRA testing +/- CXR where indicated)
7. Close contact with a sputum smear positive TB case within the last 12 weeks
Exclusion Criteria:
1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
2. History of anaphylaxis or any allergy likely to be exacerbated by any essential study procedure
3. History of currently poorly controlled of airways disease (including asthma), current cancer (except BCC of the skin or CIS of the cervix), bleeding disorder, or drug or alcohol abuse
4. Any significant autoimmune conditions or immunodeficiency (including HIV)
5. Previous diagnosis or treatment for TB disease or latent TB infection
6. Clinical, radiological, or laboratory evidence of current active TB disease
7. Previous receipt of any investigational TB vaccines or aerosolised BCG.
8. Clinically Significant abnormalities in spirometry.
9. Concurrent use of oral, inhaled or systemic steroid medication or use for more than 14 days within the last 6 months (steroids used as a cream or ointment are permissible), or the use of other immunosuppressive agents concurrently or for more than 14 days within the last 6 months
10. Use of antibiotics in the past 4 weeks.
11. Administration of immunoglobulins and/or any blood products within the three months preceding the planned study
12. Administration of a live vaccine within the preceding 28 days prior to enrolment.
13. Administration of any other non-live vaccine within the preceding 14 days prior to enrolment.
14. Pregnancy or intention to become pregnant during study period
15. Any other significant disease, disorder, or finding, which, in the opinion of the investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the study or impair interpretation of the study data
Group C Specific Exclusion Criteria
16. History of close contact with case of TB, or previous contact tracing by TB services.
Where this trial is running
Oxford, Oxfordshire and 2 other locations
- Churchill Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
- Centre for Clinical Vaccinology and Tropical Medicine — Oxford, Oxon, United Kingdom (Recruiting)
- Grove Building, Royal Free NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Helen McShane, PhD — University of Oxford
- Study coordinator: Timothy Fredsgaard-Jones, MBBS
- Email: timothy.fredsgaard-jones@ndm.ox.ac.uk
- Phone: +44 (0)1865 611385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.