PPD Challenge for Tuberculosis

Overseen By Sandra Cooper Bennett, R.N.

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Must not be taking: Anticoagulants, Immunosuppressives

Disqualifiers: Pregnancy, Respiratory dysfunction, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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....

Who Is on the Research Team?

Kevin P Fennelly, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

Adults aged 18-64, either exposed to TB without active disease or never exposed. Must be healthy with no significant medical issues like heart, lung, kidney diseases, etc., and agree to use effective contraception if of reproductive potential. Can't join if they need oxygen at rest, have HIV, poor tolerance for bronchoscopy, immunosuppressive conditions or medications usage in the last 6 months including steroids.

Inclusion Criteria

I agree to use effective birth control during the study.

I do not have any major ongoing health issues.

I am willing and able to follow the study's procedures and be available for its duration.

Exclusion Criteria

I have a history of high blood pressure in the lungs.

I do not have any immune system diseases, except for non-melanoma skin cancer.

I tested positive for COVID-19 within the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Bronchoscopy and PET-CT Procedures

Participants undergo 3 bronchoscopies and 3 FDG PET-CT scans to evaluate immune response to PPD instillation

30 days

Up to 8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tuberculin Purified Protein Derivative (PPD)

Trial Overview The trial is testing how lung cells respond to Tuberculin Purified Protein Derivative (PPD) when it's directly applied into the lungs via bronchoscopy instead of under the skin. Participants will undergo three bronchoscopies and FDG PET-CT scans over about a month with up to eight clinic visits.

How Is the Trial Designed?

Group I: 2 Experimental Treatment 1 Intervention

TST- IGRA-

Group II: 1 Experimental Treatment 1 Intervention

TST+ IGRA+

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+