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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
San Camillo Forlanini Hospital	Rome	Italy
Fondazione Istituto G. Giglio Di Cafalu	Cefalu'	Italy
Azienda Socio Sanitaria Locale N. 8 Di Cagliari	Cagliari	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uafxqkzqjq Dthdl Skkvy Dx Reun Lb Ssfjaeqg	Rome	Italy
Ahfjaib Sbfewktuv Lgtwwa Rrzu 1	Rome	Italy
Axsefdh Osuoxqwmfew Utvwlhzlskxkx Saaoml	Siena	Italy
Alrksfg Odqzygxggke Ufsfoxezhkwhc Oiauzrkx Rxfancr	Foggia	Italy
Adaqaka Stmmt Sevijqusn Ttbuaokpqxpq Doxbn Vvoqi Oigxs	Saronno	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	29.07.2019

Trial locations

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.

Investigated diseases:

Radiologically isolated syndrome

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 ID:

2024-518901-16-00

Protocol code:

BCG-RIS-01

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?