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.
Italy 
