NCT05027958CompletedEarly phase 1
Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
Background: Tuberculosis (TB) is a lung disease. It is caused by inhaling a type of airborne bacterium. Tuberculin Purified Protein Derivative (PPD) is used to test for TB exposure. It is usually injected under a person s skin. In this study, it will be applied in the lung. Objective: To learn how the cells within the lung react (immune response) when exposed to PPD. Eligibility: Adults ages 18-64 who (1) have been exposed to TB but do not have active disease or symptoms or (2) have never been exposed to TB. Design: Participants will be screened with a medical history, physical exam, and blood tests. They will have a TB skin test. They will also have an electrocardiogram to examine heart rhythm. For this, sticky patches will be placed on their chest. Some screening tests will be repeated at study visits. Participants will have 3 FDG PET-CT scans. They will lie in a machine that creates pictures of the inside of their body. They will get a radioactive substance injected into their arm called 18FDG. It helps make the pictures. Participants will have 3 bronchoscopies. Their mouth and nasal airways will be numbed. They will get drugs to relax. A tube will be inserted through their nose or mouth into a lung. Fluid will be delivered into the lung and suctioned back out to collect cells. They will get PPD during the first bronchoscopy. Participation will last for about 30 days. Participants will visit the clinic up to 8 times. They will go home after each procedure. No hospital stays are needed....
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 28 Aug 2021
- Start date
- 3 May 2022
- Primary completion date
- 7 Nov 2024
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Diseases
- Tuberculosis
- NCT number
- NCT05027958
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 17
- From 3 May 2022 to the primary completion date, 7 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Cigarette smoking, vaping or recreational drug use within the past 6 months (self-reported)
- 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
- Use of any systemic immunosuppressive medications, including corticosteroids (e.g., prednisone) or biological agents in the last 6 months prior to enrollment
- Positive for COVID-19. (with-in 6 months prior to enrollment self-reported and or via PCR)
Other illness
- 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
- Refusal or inability to undergo bronchoscopy, or a history of poor tolerance of a bronchoscopy
- 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.
- 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
Lab values
- 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
Other
- 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
- 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+)
- BMI \> 40
Criteria the registry did not label
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.