What side effects are associated with this type of intervention?

The Bacillus Calmette-Guérin (BCG) vaccine, used to prevent tuberculosis, can cause side effects such as local skin reactions, including redness, swelling, and tenderness at the injection site. In rare cases, it can lead to more serious complications like regional lymphadenitis or disseminated BCG infection, particularly in immunocompromised individuals. Other common TB treatments, such as isoniazid, rifampin, ethambutol, and pyrazinamide, can cause side effects including liver toxicity, gastrointestinal disturbances, and peripheral neuropathy.

What prior FDA approvals exist?

The Bacillus Calmette-Guérin (BCG) vaccine is a well-known treatment for tuberculosis that works by stimulating the immune system to provide protection against the disease. While the BCG vaccine itself is not FDA-approved for use in the United States, it is widely used globally. Other FDA-approved drugs for tuberculosis treatment include antibiotics such as isoniazid, rifampin, ethambutol, and pyrazinamide, which are used in combination to treat active TB infections. These antibiotics work by targeting the bacteria directly, unlike the BCG vaccine, which aims to boost the immune response.

What other types of research exist?

Promising novel alternatives to the BCG vaccine for tuberculosis patients include subunit vaccines like M72/AS01E, viral vector vaccines such as Ad5 Ag85A, and recombinant protein vaccines like H4:IC31. These vaccines are in various stages of clinical trials and show potential for improved efficacy and safety compared to the traditional BCG vaccine.

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Vaccine

BCG Vaccine for Tuberculosis Prevention (TIPI Trial)

Phase 3

Recruiting

Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is male or female, age ≥ 18 years and ≤ 65 years at time of consent

Participant has no known history of Mtb infection

Must not have

Participant is currently receiving (within last 30 days) immune-compromising treatments, such as TNF-α blockade

Participant has received 2 or more live vaccinations (e.g., measles and yellow fever) within 30 days prior to receipt of BCG/placebo vaccine (Visit 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-6 months from return post-travel

Awards & highlights

Pivotal Trial

Summary

This trial is testing if a single dose of the BCG vaccine can help prevent TB in healthy adults traveling to countries where TB is common. The vaccine works by preparing the immune system to fight off TB bacteria. Participants will receive either the BCG vaccine or a non-active substance. BCG is currently the only available vaccine against TB, widely used but with variable efficacy in adults.

Who is the study for?

Adults aged 18-65 planning to travel to high TB risk countries, in good health, with no prior BCG vaccination or history of TB infection. They must agree to avoid pregnancy, breastfeeding for specific periods post-vaccination and forego certain skin tests for 6 months.

What is being tested?

The trial is testing if the BCG (Tokyo 172) vaccine can prevent tuberculosis in adults traveling to high-risk areas compared to a placebo. Participants will be randomly assigned either the vaccine or placebo before their travel.

What are the potential side effects?

Possible side effects include soreness at injection site, mild fever, and swelling of lymph nodes. As it's an experimental vaccine in the US, there may be unknown risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have never had a tuberculosis infection.

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I have never received a BCG vaccine or been part of a tuberculosis vaccine trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on treatments that weaken my immune system.

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I have had 2 or more live vaccines in the last 30 days before getting the BCG/placebo vaccine.

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I have received BCG treatment for my bladder cancer.

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I cannot receive the BCG vaccine due to a condition like HIV.

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I have had a nontuberculous mycobacterial infection before.

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I am currently pregnant, planning to become pregnant soon, or am breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 months from return post-travel

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-6 months from return post-travel

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 months from return post-travel for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Secondary study objectives

Communicable Diseases

Number of Participants with history of TB disease/symptoms while deployed

Number of Participants with self-reported symptoms of all-cause respiratory infections acquired while traveling abroad

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BCG vaccineExperimental Treatment1 Intervention

Freeze-dried Glutamate Bacillus Calmette-Guérin (BCG) (Tokyo 172) vaccine

Group II: PlaceboPlacebo Group1 Intervention

Vaccine diluent \[sodium glutamate\]

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Tuberculosis (TB) include antibiotics such as isoniazid, rifampin, ethambutol, and pyrazinamide, which work by targeting and killing the Mycobacterium tuberculosis bacteria. The BCG vaccine, which is being studied for its potential to prevent TB infection, works by stimulating the immune system to recognize and fight the TB bacteria more effectively. Understanding these mechanisms is crucial for TB patients as it helps in selecting the appropriate treatment regimen, ensuring better management of the disease, and potentially improving outcomes by preventing the development of drug-resistant TB strains.