BCG vaccine for preventing multiple sclerosis in patients with radiologically isolated syndrome

Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)

This study is testing if the BCG vaccine can help people with Radiologically Isolated Syndrome avoid developing multiple sclerosis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: S. Andrea Hospital (Academic / other)
• Locations: 1 site (Rome)
• Trial ID: NCT03888924 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of the Bacille Calmette-Guerin (BCG) vaccine in patients diagnosed with Radiologically Isolated Syndrome (RIS) to prevent the onset of multiple sclerosis (MS). The study aims to address unmet needs in MS treatment by exploring safe and manageable therapies that can be administered early in the disease process. Participants will be randomly assigned to receive either the BCG vaccine or a placebo, with the goal of assessing the vaccine's efficacy in preventing the clinical onset of MS. The trial will also incorporate genetic data and biomarkers to enhance the understanding of disease progression.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with Radiologically Isolated Syndrome within the last five years.

Not a fit: Patients who are pregnant, lactating, or have a history of significant immunosuppressive treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive treatment option for patients at risk of developing multiple sclerosis.

How similar studies have performed: Previous studies have shown encouraging results with the BCG vaccine in early MS and clinically isolated syndrome, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Male and female of any race and \> 18 years old.
2. Diagnosis of RIS (4) within the last five years.
3. Signed Informed Consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Concomitant or previous use of immunosuppressive or immunomodulating treatment (except sporadic use of corticosteroids) within the last five years.
3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, severe systemic mycotic infections, metabolic diseases or malignancies, primary or secondary immunodeficiencies as determined by medical history, physical exam, laboratory tests, chest X-ray, electrocardiogram (ECG), and Mantoux reaction.
4. Any medical or psychiatric condition that may affect the subjects ability to give informed consent, or to complete the study, or if the subject is considered by the treating neurologist to be, for any other reason, an unsuitable candidate for this study.
5. Subjects with inability to successfully undergo MRI scans.
6. Concomitant radiotherapy.
7. Known hypersensitivity to any component of the vaccine.
8. Past bone marrow stem cell transplantation and organ transplantation.
9. Other vaccinations in the previous 4 weeks.

Where this trial is running

Rome

• Center for Experimental Neurological Therapies (CENTERS), S. Andrea Hospital, Faculty of Medicine and Psychology, "Sapienza" University of Rome — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Giovanni Ristori — S.Andrea Hospital, University of Roma La Sapienza
• Study coordinator: Giovanni Ristori, MD

Conditions Multiple Sclerosis; BCG Vaccine; Radiologically Isolated Syndrome