Scientists peer inside lungs to unlock TB immune secrets
NCT ID NCT05027958
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how immune cells in the lungs respond to tuberculosis (TB) proteins in 17 adults—some with latent TB (no symptoms) and some never exposed. Researchers used a thin tube to deliver the protein directly into the lung and collected cells to measure immune reactions. The goal was to better understand lung-specific immunity, not to treat or cure TB.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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17 people
The number who actually took part.
- Started
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May 2022
- Finished
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Dec 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Adults 18-64 years old will be recruited for the two groups (non-LTBI controls vs confirmed LTBI). The lower limit of this age range is based on the need for invasive bronchoscopic procedures and exposure to radiation, both of which carry more risk at younger ages. In addition, most adults present with post-primary or reactivation TB that most often occurs radiographically in the upper lobes of the lungs, often with cavitation. Conversely, children and rare adults with primary TB have non-cavitary disease in the lower lobes. The higher limit of this age range is based on the known property of immune senescence, i.e., the waning of the strength of immune responses with advancing age. In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Ability of subject to understand and the willingness to sign a written informed consent document. * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 - 64 years of age * No significant active medical problems. This would include but not limited to any cardiac disorder (e.g. arrhythmia, valvular disease), pulmonary disease (e.g. asthma requiring chronic medications, chronic bronchitis, emphysema, obstructive sleep apnea), kidney disease (e.g. nephritis, nephrosis), rheumatologic disorder (e.g. inflammatory arthritis), endocrine disorder (e.g. diabetes, thyroid disease), liver disease (e.g. hepatitis), gastrointestinal disorder (e.g. inflammatory bowel disease) or infectious disease (e.g. active tuberculosis). * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and agreement to use such a method during study participation EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Pregnancy as assessed by urinary or plasma HCG or breastfeeding * History of clinically significant respiratory dysfunction 3 months prior to participating * Evidence of new pulmonary infection * History of any chronic lung infections or chronic lung disease * History of pulmonary hypertension * Need for supplemental oxygen administration at rest * Current use or inability to suspend use of anticoagulant therapy including platelet inhibitors (e.g. clopidogrel) within 7 days of study bronchoscopy or systemic anticoagulants (e.g. warfarin, enoxaparin, or DOAC) within 14 days of study bronchoscopy * Any symptoms consistent with infection including fever, chills, night sweats, or unexplained weight loss * A history of a necrotic reaction to a tuberculin skin test, including during screening * A history of human immunodeficiency virus (HIV) infection * A history of coughing up blood in the last 3 months * Cigarette smoking, vaping or recreational drug use within the past 6 months (self-reported) * If there is any discrepancy in tuberculin skin test and Interferon Gamma Release Assay test results (i.e. PPD+ but IGRA- or PPD- but IGRA+) * Refusal or inability to undergo bronchoscopy, or a history of poor tolerance of a bronchoscopy * If undergoing PET-CT imaging during this study places a participant over his/her annual radiation dose limit. Radiation exposure within the previous 12 months of \>= 2.3 rem * BMI \> 40 * Diabetes * Known life-threatening allergic reaction to Tuberculin, Lidocaine, Midazolam, Fentanyl or medications of similar classes * Presence of any immunosuppressive diseases, including cancers with the exception of non-melanomatous skin cancer. * Use of any systemic immunosuppressive medications, including corticosteroids (e.g., prednisone) or biological agents in the last 6 months prior to enrollment * Any medical, psychiatric, social condition, occupational reason or other responsibility, in the judgement of the investigator, that is a contraindication to protocol participation or impairs a participant s ability to give informed consent * Positive for COVID-19. (with-in 6 months prior to enrollment self-reported and or via PCR)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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