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

RecruitingPhase 2Ages 18 Years - anyAllS. Andrea Hospital
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In plain words

What the trial is, and whether it could suit you

Multiple sclerosis (MS) witnessed relevant therapeutic progress in the last decade. Following the extraordinary progress in the treatment of relapsing-remitting (RR) multiple sclerosis (MS), two major unmet needs remain to be addressed by translational research in this field: progressive MS and the "dream" of a world free of MS. As far as the latter is concerned, the investigators can hope to make the dream come true by understanding the etiology of the disease and hence design definitive cures. A more realistic and pragmatic perspective may be the prevention of the clinical onset of the disease, a research field that promises to become increasingly important as the integration of genetic data with endophenotypes, magnetic resonance imaging and other biomarkers ameliorates the ability to predict the development of the disease under clinical circumstance. Bacille Calmette-Guerin (BCG) vac

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Bacille Calmette-Guerin vaccine
  • Placebo
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Where

1 site
Center for Experimental Neurological Therapies (CENTERS), S. Andrea Hospital, Faculty of Medicine and Psychology, "Sapienza" University of Rome
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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