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Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)

ConditionsMycobacterium Avium-intracellulare InfectionMycobacterium Infections, Nontuberculous
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine

    Biological/Vaccine

    Subjects will be randomized to a single intradermal injection of BCG or placebo vaccine. Participants randomized to the BCG arm will receive TICE® BCG. Freeze-dried vaccine is produced in vials, each containing 1 to 8 x\^108 colony forming units (CFU). A vial will be reconstituted in 20 mL of preservative-free saline. Administration of 0.1 mL will contain \~2x\^106 CFU, which accounts for approximately 0.25 mg of the attenuated Mycobacterium bovis. Administration of 0.1 mL of diluted vaccine will be given per dose, intradermally.

  • preservative-free saline

    Drug

    Patients randomized to the placebo arm will receive 0.1 mL preservative-free saline alone.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Active BCGActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Safety and tolerability of intradermal BCG (TICE®) in this patient population, compared to placebo, assessed by weekly questionnaire of adverse events. Licensed study team member will follow-up on any events reported to be more than mild. Follow-up will be completed as a telemedicine or in person visit

Time frame
12 weeks after intervention
2

Serious adverse events

Serious adverse events related to the intradermal BCG over 12 months after intervention.

Time frame
12 months
3

Immunogenicity

Compare changes in immunogenicity, as measured by IFN-gamma production between the BCG and placebo groups. We will assess for increases in T cell immune responses against BCG and MAC, as measured by cytokine production, in those who received the BCG vaccine and those that received placebo. We will use ex vivo T cell stimulation assays to quantify the antigen specific T cell responses and assess cytokine production via flow cytometry and/or multiplexed enzyme-linked immunosorbent assay (Luminex).

Time frame
24 months

Secondary outcomes

1

Sputum cultures

Compare proportion of sputum cultures positive for MAC between the two groups

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov
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