Characteristics of the early immune response in airway and blood in people with latent tuberculosis (TB) infection and active TB disease.

Not Applicable

• Conditions: Tuberculosis; Infections and Infestations

• Registration Number: ISRCTN17985576
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-10
• Last Update Posted: 29 April 2024
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Current inclusion criteria as of 02/11/2023:

1. Provision of informed consent.
2. Aged 16 years or older.
3. Engagement with the Leicester Clinical TB service with either suspected TB or as a recent contact of active TB disease.
4. Healthy controls with no evidence of active TB disease or LTBI.

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Previous inclusion criteria:

1. Provision of informed consent.
2. Aged 18 to 84 years.
3. Engagement with the Leicester Clinical TB Service with either suspected active TB disease or as a recent contact of active TB disease.
4. Healthy controls will be recruited from the same cohort after investigations have identified no evidence for active TB disease or LTBI.

Exclusion Criteria

Current exclusion criteria as of 02/11/2023:

1. Any chronic medical disorder which, in the opinion of the investigator, may either put the subject at risk (because of participating in the study) or may influence the results of the study or the subjects’ ability to participate in the study.
2. Donation of blood >450ml within 3 months of study commencement or during the study (other than for study purposes).
3. Pregnancy or lactation.
4. Participation in an interventional clinical study in the 3 months prior to of Visit 1 or participation in a study using interventional medicinal products in the previous 6 months.
5. Proven immunosuppression, including diagnosed immunodeficiency disorders and treatment with immunosuppressive medication, including oral corticosteroids at any dose.
6. Previous chemotherapy for LTBI in the last 5 year.
7. Previous treatment for active TB disease in the last 2 year.

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Previous exclusion criteria:

1. History of any acute infection in the previous 4-6 weeks
2. Any chronic medical disorder which, in the opinion of the investigator, may either put the subject at risk (because of participating in the study) or may influence the results of the study or the subjects' ability to participate in the study.
3. Donation of blood > 450ml within 3 months of study commencement or during the study (other than for study purposes).
4. Pregnancy or lactation.
5. Participation in an interventional clinical study in the 3 months prior to Visit 1 or participation in a study using interventional medicinal products in the previous 6 months.
6. Proven immunosuppression, including diagnosed immunodeficiency disorders and treatment with immunosuppressive medication, including oral corticosteroids at any dose.
7. Previous chemotherapy for LTBI.
8. Previous treatment for active TB disease.
9. Aged 85 or over

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early immune response in the airway of patients with latent TB infection is determined using cellular and transcriptional profiling (flow cytometry and RNA sequencing) at baseline and 3 months.

Secondary Outcome Measures

Name	Time	Method
1. Early immune response in the airway of patients with Active TB infection and LTBI progressors are determined using the cellular and transcriptional profiling at baseline. <br>2. Longitudinal changes in immune response in latent TB infection is determined by assessing changes in the transcriptional gene signatures <br>(bioinformatics analyses to identify signatures from RNA seq data) over 2 years. <br>3. Comparison of blood and airway transcriptional profiles (RNA sequencing) in active TB and latent TB infection.