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Study of BCG Vaccine and Sodium Chloride for Patients with Radiologically Isolated Syndrome (RIS)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Radiologically Isolated Syndrome (RIS). RIS is a situation where changes are seen in the brain through imaging tests, but the person does not show any symptoms of a disease. The study will use the Bacille Calmette-Guérin (BCG) vaccine, which is traditionally used to prevent tuberculosis. The purpose of the study is to observe the effects of the BCG vaccine on RIS over a period of one year.

Participants in the study will receive the BCG vaccine through an injection just under the skin, known as an intradermal injection. Another group of participants will receive a placebo, which looks like the vaccine but does not contain any active ingredients. The study will monitor the number of new changes in the brain using magnetic resonance imaging (MRI) scans over the course of a year. These scans help doctors see detailed images of the brain to track any new developments.

Throughout the study, researchers will also keep an eye on the time it takes for any clinical symptoms to appear over a three-year period. They will look at various aspects of brain health, such as the number of specific types of brain lesions, changes in brain volume, and other detailed measurements. The safety and tolerability of the vaccine will also be assessed by monitoring any side effects or changes in laboratory test results during the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that the informed consent form is signed. This confirms understanding and agreement to participate in the trial.

  2. Step 2

    Initial assessment

    Undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of Radiologically Isolated Syndrome (RIS) within the last five years and confirming age requirements.

  3. Step 3

    Medication administration

    Receive the BCG vaccine. This is a powder and solvent for suspension, administered through an injection into the skin (intradermal use).

    The vaccine is given to assess its effect on the number of new active lesions in the brain over a period of one year.

  4. Step 4

    Regular monitoring

    Attend regular appointments for MRI scans. These scans are used to monitor the number of new active lesions in the brain.

    The primary goal is to assess changes over a one-year period.

  5. Step 5

    Safety and tolerability checks

    Report any adverse events or side effects experienced during the study. This is important for evaluating the safety and tolerability of the treatment.

    Regular laboratory tests may be conducted to ensure safety.

  6. Step 6

    Follow-up period

    Continue to be monitored for up to three years to observe the time to the first clinical event and other exploratory endpoints.

    This includes tracking changes in brain volume and other specific brain measurements.

Who can join the trial?

4 criteria

  • Must be a male or female of any race.
  • Must be over 18 years old.
  • Must have a diagnosis of RIS (Radiologically Isolated Syndrome) within the last five years.
  • Must have signed an Informed Consent, which means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

  • Patients with any medical condition other than Radiologically Isolated Syndrome (RIS) cannot participate. RIS is a condition where changes are seen in the brain on an MRI scan, but the person does not have any symptoms.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you fit the required age group.
  • Patients who are part of a vulnerable population, which may include groups like pregnant women, children, or those unable to give consent, cannot participate.
  • Patients who do not meet the specific health and safety requirements set by the study cannot participate. These requirements ensure the safety and well-being of participants.
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Investigated drugs

Bacille Calmette-Guérin (BCG) Vaccine is a vaccine primarily used against tuberculosis. In this clinical trial, it is being tested for its potential effects on a condition called Radiologically Isolated Syndrome (RIS). The goal is to see if the BCG vaccine can help reduce the number of new active lesions in the brain, which are detected through MRI scans. These lesions are important because they can be an early sign of multiple sclerosis. The trial aims to find out if the BCG vaccine can slow down or prevent the progression of RIS by reducing these lesions over a year.

What is already known about the treatment

Bacille Calmette-Guérin (BCG) Vaccine – The BCG vaccine is typically administered as an injection into the skin. It is currently being studied in clinical trials for its potential use in treating Radiologically Isolated Syndrome (RIS), a condition identified by specific changes in MRI scans. The main therapeutic indication being explored is its ability to reduce the number of new active lesions in the brain over a year. At the molecular level, the BCG vaccine is thought to work by stimulating the immune system to help control inflammation and potentially prevent the progression of neurological changes. It is classified pharmacologically as a vaccine, traditionally used for tuberculosis prevention, but now being investigated for its broader immunomodulatory effects.

Investigated diseases

Radiologically Isolated Syndrome (RIS) – Radiologically Isolated Syndrome is a condition identified through MRI scans, where individuals show brain lesions similar to those seen in multiple sclerosis, but without any clinical symptoms. These lesions are typically found in the white matter of the brain and may be detected incidentally during imaging for other reasons. Over time, some individuals with RIS may develop symptoms that lead to a diagnosis of multiple sclerosis, but not all do. The progression of RIS is monitored through regular MRI scans to track changes in the number and size of lesions. The condition is characterized by the presence of new or expanding lesions on MRI, which may or may not eventually lead to clinical symptoms. RIS itself does not cause symptoms, but it is a marker for potential future neurological changes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518901-16-00Protocol codeBCG-RIS-01Estimated enrolment100 patientsSponsorFondazione Italiana Sclerosi Multipla Ente Del Terzo Settore/et S

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