Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
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) vaccine has been
tested with encouraging results in early MS and clinically isolated syndrome (CIS). The
knowledge that disease-modifying therapies work best when used early in the demyelinating
process raises the question about whether to try this approach - which is safe, cheap and
handy - in individuals with radiologically isolated syndrome (RIS).
Radiologically isolated syndrome is a new entity, diagnosed when the unanticipated magnetic
resonance imaging (MRI) finding of brain spatial dissemination of focal white matter (WM)
lesions highly suggestive of MS occurs in subjects without symptoms of MS, and with normal
neurological examinations. Conversion to clinically isolated syndromes (CIS) were described
in 84% of RIS individuals with spinal cord lesions over a median time of 1.6 years from the
date of the first MRI. Whether or not to treat this condition remains currently a clinical
conundrum. Bacille Calmette-Guérin (BCG) vaccine may have these characteristics since it
resulted beneficial in early MS and first demyelinating episodes. Being safe, cheap and
handy, the investigators propose to investigate its use to prevent progression of the
demyelinating process in radiologically isolated syndrome. An approach such as BCG vaccine
seems appropriate as a front-line immunomodulatory approach for RIS people. In a pilot study
BCG vaccine was safe and effective in reducing disease activity at MRI, and the risk of
developing persistent T1-hypointense lesions ('black holes' -BH- expression of tissue damage)
in subjects with MS.