Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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
Eligibility criteria
Qualifiers
Male or female aged ≥18 years
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine
- preservative-free saline
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov