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Tests treatment safety and results for Mycobacterium Avium-intracellulare Infection
Official title Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
ClinicalTrials.gov ID: NCT07094711
What this study is testing
What is Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine?
Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for mycobacterium avium-intracellulare infection.
Also referred to as TICE® BCG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out if the Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine can be used safely to treat Mycobacterium avium complex (MAC) lung disease. Researchers will compare responses from patients with MAC lung disease after receiving an injection of BCG or placebo (a look-alike substance that contains no drug) Participants in the study: Receive a BCG or placebo injection at UVA study center on Day 0 Come to UVA study center on Day 60 Come to UVA study center at the end of the study Answer surveys and questionnaires about how you are doing Have blood drawn 3 times, on injection day, day 60, and at end of study Give the study team personal and demographic information Discuss any new symptoms with the study team Provide monthly sputum samples per usual care
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female aged ≥18 years
- Mycobacterium avium complex lung disease as evidenced by diagnosis or treatment for MAC lung disease by pulmonologist or infectious disease physician...
- History of at least 2 MAC positive respiratory cultures, one of which is within 1 year of enrollment. In the event a MAC positive culture is from...
- Respiratory and/or constitutional symptoms consistent with MAC lung disease
You likely can't join if
- Selection of study participants will be equitable, but an individual who meets any of the following criteria will be excluded from participation in...
- Currently receiving antibiotics prescribed for their MAC lung disease
- Having received any antibacterial antibiotics within the past 14 days prior to study vaccination, day 0
- Known allergy, intolerance or other contraindication to isoniazid or rifampin or ethambutol
- Expectation of starting anti-MAC lung disease antibiotics in the next 2 months per patient or their physician
- Persons with congenital or acquired immune deficiencies (e.g., HIV infection; leukemia, lymphoma, or cancer therapy within the past 2 years...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female aged ≥18 years
- Mycobacterium avium complex lung disease as evidenced by diagnosis or treatment for MAC lung disease by pulmonologist or infectious disease physician in the medical record. The following data will be extracted from the...
- History of at least 2 MAC positive respiratory cultures, one of which is within 1 year of enrollment. In the event a MAC positive culture is from bronchial lavage or biopsy, one culture rather than 2 will meet criteria.
- Respiratory and/or constitutional symptoms consistent with MAC lung disease
- Nodular or cavitary opacities on chest radiograph or bronchiectasis with multiple small nodules on high-resolution computed tomography
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures
- Women of childbearing potential (WOCBP) (i.e., fertile following menarche and until becoming postmenopausal unless permanently sterile) agree to practice a highly effective method of birth control from Day 0 to at least...
- True abstinence (refraining from heterosexual intercourse during the entire study),
- Copper intrauterine device (IUD),
- Hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill [combined with barrier method]), exclusive homosexual relationship) sole male partner who has...
- Selection of study participants will be equitable, but an individual who meets any of the following criteria will be excluded from participation in this study:
- Currently receiving antibiotics prescribed for their MAC lung disease
- Having received any antibacterial antibiotics within the past 14 days prior to study vaccination, day 0
- Known allergy, intolerance or other contraindication to isoniazid or rifampin or ethambutol
- Expectation of starting anti-MAC lung disease antibiotics in the next 2 months per patient or their physician
- Persons with congenital or acquired immune deficiencies (e.g., HIV infection; leukemia, lymphoma, or cancer therapy within the past 2 years; immunosuppressive therapy such as anti B cell depleting therapies...
- Prior BCG Vaccination. If unknown Bcgatlas.org shall be consulted for local vaccination administration policies.
- Known pregnancy at the time of screening or breastfeeding at the time of enrollment (pregnancy test negative at baseline if applicable)
- Cystic fibrosis
- Active tuberculosis: Active tuberculosis (respiratory AFB culture growing Mycobacterium tuberculosis complex within the past 4 months).
- Known exposure to a case of active pulmonary tuberculosis within 10 weeks of enrollment
- Known prior hypersensitivity reaction to BCG or any component of the BCG vaccine
- Received live injectable vaccine within 28 days of day 0 study vaccination
- Any condition in the opinion of the investigator that may confound the study endpoints Note that colonization or co-infection with other nontuberculous mycobacteria is not exclusionary, as MAC will be the endpoint.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.