BCG Vaccine for Nontuberculous Mycobacterial Infections

(BOOST Trial)

Overseen By Eric R Houpt, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Must not be taking: Antibiotics, Immunosuppressants

Disqualifiers: Pregnancy, Cystic fibrosis, Active tuberculosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the BCG vaccine, originally used for tuberculosis, can safely treat lung disease caused by Mycobacterium avium complex (MAC). Researchers will compare the effects of the BCG vaccine to a placebo to assess its effectiveness. Suitable candidates for this trial include adults diagnosed with MAC lung disease by a doctor, who have symptoms such as breathing issues or visible lung changes on X-rays. Participants will receive an injection, provide blood and sputum samples, and complete surveys throughout the study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

If you are currently taking antibiotics for your MAC lung disease or have taken any antibacterial antibiotics in the past 14 days, you cannot participate in the trial. The trial does not specify other medication restrictions, so it's best to discuss your current medications with the study team.

Will I have to stop taking my current medications?

If you are currently taking antibiotics for your MAC lung disease or have taken any antibacterial antibiotics in the past 14 days, you cannot participate in the trial. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that the BCG vaccine is likely to be safe for treating MAC lung disease?

Research has shown that the BCG vaccine, typically used to prevent tuberculosis, is generally safe and also offers protection against some other infections. Although the vaccine has been used worldwide for a long time, researchers are still gathering specific information about its use in treating Mycobacterium avium complex (MAC) lung disease.

Previous studies have found that the BCG vaccine rarely causes serious side effects. Most individuals experience only mild reactions, such as swelling at the injection site or a slight fever. Serious side effects are uncommon. However, there is insufficient information about its use during pregnancy, so pregnant individuals should exercise caution.

This treatment is currently in the middle phase of clinical trials. While some evidence suggests it is safe, more information is needed to fully understand its effects for this condition. Researchers will closely monitor participants to ensure any new symptoms or side effects are promptly addressed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for nontuberculous mycobacterial (NTM) infections, which often involve prolonged courses of antibiotics, the BCG vaccine offers a unique biological approach. The vaccine contains a live, attenuated strain of Mycobacterium bovis, which is designed to boost the body's immune response against mycobacterial infections. Researchers are excited about this treatment because it targets the problem by enhancing the immune system rather than relying solely on antibiotics, potentially reducing the need for long-term antibiotic use and minimizing the risk of antibiotic resistance. This novel approach could lead to more effective and sustainable management of NTM infections.

What evidence suggests that the BCG vaccine might be an effective treatment for MAC lung disease?

Research has shown that the BCG vaccine can help protect against certain lung infections, including Mycobacterium avium complex (MAC) lung disease. Although the vaccine's effectiveness may decrease over time, it still offers some protection. Known for its long-term use against tuberculosis, a serious lung disease, the BCG vaccine has also been used for other similar infections. In this trial, participants will receive either the active BCG vaccine or a placebo. These findings suggest that the BCG vaccine might help treat MAC lung disease, prompting further studies. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with MAC lung disease, a type of nontuberculous mycobacterial infection. Participants will visit the UVA study center for injections and follow-ups, answer health surveys, have blood drawn three times, discuss symptoms with researchers, and provide monthly sputum samples.

Inclusion Criteria

My chest scan shows nodules or cavities.

I have been diagnosed or treated for MAC lung disease by a specialist.

Stated willingness to comply with all study procedures

Exclusion Criteria

Known pregnancy at the time of screening or breastfeeding at the time of enrollment

Known prior hypersensitivity reaction to BCG or any component of the BCG vaccine

Persons with congenital or acquired immune deficiencies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a BCG or placebo injection and are monitored for safety and immunogenicity

12 weeks

3 visits (in-person) on Day 0, Day 60, and at the end of the study

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monthly sputum samples and adverse event assessments

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine

Trial Overview The study tests if the BCG vaccine can safely treat MAC lung disease by comparing patient responses to either a BCG injection or a placebo (a substance with no drug). The trial involves an initial injection at the study center followed by visits on Day 60 and at the end of the study.

How Is the Trial Designed?

Group I: Active BCG Active Control 1 Intervention

Biological/Vaccine: Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine

Group II: Placebo Placebo Group 1 Intervention

preservative-free saline

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11101679/

Effects of non-tuberculous mycobacteria on BCG vaccine ... The aim of this study was to review the findings of the studies focusing on the effects of NTM on BCG vaccine efficacy in animal models.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666524724002143

Effectiveness of the primary Bacillus Calmette-Guérin ... Results from a larger set of household contacts suggest that BCG vaccination is ineffective in adolescents, which might have influenced the outcomes of the ACS ...

3. journals.asm.org journals.asm.org/doi/10.1128/microbiolspec.TNMI7-0003-2016

Mycobacterium bovis BCG and New Vaccines for the ... BCG has clear and sustained efficacy, but after 10 years, its efficacy appears to wane, at least in some populations. Fortunately, there are many new ...

4. nature.com nature.com/articles/nrmicro1211

The success and failure of BCG — implications for a novel ... The Mycobacterium bovis bacille Calmette–Guérin (BCG) vaccine against tuberculosis (TB) has maintained its position as the world's most widely used vaccine.

5. en.wikipedia.org en.wikipedia.org/wiki/BCG_vaccine

BCG vaccine BCG also has some effectiveness against Buruli ulcer infection and other nontuberculous mycobacterial infections. Additionally, it is often used as part ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538185/

Bacillus Calmette Guerin - StatPearls - NCBI Bookshelf - NIH BCG vaccine also offers protection against non-tuberculous mycobacterial infections like leprosy and Buruli ulcer. It is also used in the treatment of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07094711

Study Details | NCT07094711 | Safety, Immunogenicity, ... 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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666634021003809

Protection against tuberculosis by Bacillus Calmette ... Although BCG protects against Mycobacterium tuberculosis infection and TB disease, the level of protection varies greatly between age groups and settings.