Lung Innate Immunity and Microbiome After Tuberculosis Exposure

NCT06526689 | Recruiting

• 1 other identifier: LIMBO-TB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

To characterise the innate pulmonary immune response and respiratory microbiome after recent exposure to M.tb and to evaluate how differences determine the outcome of M.tb exposure

Conditions

Tuberculosis; Latent Tuberculosis

Outcome Measures

Primary Outcomes (1)

• The immunological response after recent M.tb exposure measured as the differentials of innate immune cells in the blood and sputum.

  We will characterise the number and activity of early immunological response to M.tb in the respiratory tract and systemic circulation. Samples of blood and sputum will be utilised to enumerate the proportions of innate immune cells measured by flow cytometry and their activity.

  At enrolment and Day 84

Secondary Outcomes (1)

• An assessment of respiratory microbiome diversity in M.tb contacts compared to healthy controls

  At enrolment and Day 84

Other Outcomes (1)

• Exploratoring the role of innate immune response and microbiome on determining infection status by M.tb

  At enrolment and Day 84

Study Arms (3)

Group A

Adult volunteers who are recent contacts of Mycobacterium tuberculosis sputum smear positive cases with positive IGRA

Group B

Adult volunteers who are recent contacts of Mycobacterium tuberculosis sputum smear positive cases with negative IGRA

Group C

Healthy adult volunteers with no previous exposure to Mycobacterium tuberculosis.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Human Adults with and with our recent exposure to M.tb

You may qualify if:

• 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 the investigators to review the volunteer's review NHS care record, medical history, blood results and radiographs.
• Able and willing (in the investigator's opinion) to comply with all study requirements
• Have undergone screening for TB through NHS services (including IGRA testing +/- CXR where indicated)
• Close contact with a sputum smear positive TB case within the last 12 weeks

You may not qualify if:

• Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
• History of anaphylaxis or any allergy likely to be exacerbated by any essential study procedure
• 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
• Any significant autoimmune conditions or immunodeficiency (including HIV)
• Previous diagnosis or treatment for TB disease or latent TB infection
• Clinical, radiological, or laboratory evidence of current active TB disease
• Previous receipt of any investigational TB vaccines or aerosolised BCG.
• Clinically Significant abnormalities in spirometry.
• 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
• Use of antibiotics in the past 4 weeks.
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned study
• Administration of a live vaccine within the preceding 28 days prior to enrolment.
• Administration of any other non-live vaccine within the preceding 14 days prior to enrolment.
• Pregnancy or intention to become pregnant during study period
• 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

Sponsors & Collaborators

• University of Oxford: lead
• University College, London: collaborator

Study Sites (3)

Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

Centre for Clinical Vaccinology and Tropical Medicine

Oxford, Oxon, OX3 9DZ, United Kingdom

RECRUITING

Grove Building, Royal Free NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples Sputum Samples

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Helen McShane, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Fredsgaard-Jones, MBBS

CONTACT

+44 (0)1865 611385; timothy.fredsgaard-jones@ndm.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: July 30, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

GB (3)