Lung Innate Immunity and Microbiome After Tuberculosis Exposure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Oxford
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
Human Adults with and with our recent exposure to M.tb
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 3 trial groupsGroup A: Group A
Group B: Group B
Group C: Group C
Trial outcomes
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.
Time frame
At enrolment and Day 84Secondary outcomes
1
An assessment of respiratory microbiome diversity in M.tb contacts compared to healthy controls
To characterise the respiratory microbiome after exposure to M.tb by identifying bacterial genetic sequences and calculating both alpha diversity and beta diversity of sputum samples. Baseline and followup sample at day 84 will be investigated to determine robustness of communities.
Time frame
At enrolment and Day 84Other outcomes
1
Exploratoring the role of innate immune response and microbiome on determining infection status by M.tb
We will combine data on the microbial communities identified in sputum as well as their diversity and combine it with data on the innate immune responses to explore whether measurements can be used to predict latent TB infection. Utilised assays may include but will not be limited to: Flow cytometry ELISAs Ellispots Sequencing data of bacterial isolates from sputum samples.
Time frame
At enrolment and Day 84Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
University College, London
Collaborator
Source ClinicalTrials.gov