Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis
Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Bacille of Calmette-Guerin
Placebo
- placebo
What it measured
Main measures
number of gad-enhancing lesions in T1
baseline and 6 months
MRI lesionsnumber of lesions in T1 and new lesions in T2
baseline and 6 months
MRI lesions
Other measures (2)
volume of T2 lesions
0 and 6 months
MRI lesionsvolume of T1 lesions (black holes)
0 and 6 months
MRI lesions
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Patients with an initial disease (diagnosis supported by paraclinical criteria): single clinical poly or mono-symptomatic attack in the 6 months preceding the study, MR picture compatible with MS
Exclusion criteria
* Therapy with corticosteroids in the last month * Plasmapheresis, administration of gamma globulins in the last three months * Serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams * Evidence of infections * Evidence of tubercular disease
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The frequency of auto-immune diseases (including multiple sclerosis) is increasing in industrialised countries. According to an hypothesis which is receiving a wide international credit, this may be due to the fact that the populations of these countries are increasingly less exposed to microbes further to the improvement of hygienic conditions and to the use of antibiotics. If exposure to microbes is lacking, also their regulatory function is missed with a consequent possible onset of auto-immune symptoms. For this reason, it is deemed that by exposing the immune system of a patient to an ancient microbe, being complex and important in man evolution, like the Tuberculosis Mycobacterium, it is possible to rebalance the immune system.
Papers
Results
Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.Neurology · 2014
Background
Ristori G, Buzzi MG, Sabatini U, Giugni E, Bastianello S, Viselli F, Buttinelli C, Ruggieri S, Colonnese C, Pozzilli C, Salvetti M. Use of Bacille Calmette-Guerin (BCG) in multiple sclerosis. Neurology. 1999 Oct 22;53(7):1588-9. doi: 10.1212/wnl.53.7.1588.Background
Salvetti M, Pisani A, Bastianello S, Millefiorini E, Buttinelli C, Pozzilli C. Clinical and MRI assessment of disease activity in patients with multiple sclerosis after influenza vaccination. J Neurol. 1995 Feb;242(3):143-6. doi: 10.1007/BF00936886.Background
Confavreux C, Suissa S, Saddier P, Bourdes V, Vukusic S; Vaccines in Multiple Sclerosis Study Group. Vaccinations and the risk of relapse in multiple sclerosis. Vaccines in Multiple Sclerosis Study Group. N Engl J Med. 2001 Feb 1;344(5):319-26. doi: 10.1056/NEJM200102013440501.Background
Rook GA, Ristori G, Salvetti M, Giovannoni G, Thompson EJ, Stanford JL. Bacterial vaccines for the treatment of multiple sclerosis and other autoimmune disorders. Immunol Today. 2000 Oct;21(10):503-8. doi: 10.1016/s0167-5699(00)01700-x. No abstract available.Background
Buttinelli C, Salvetti M, Ristori G. Vaccinations and multiple sclerosis. N Engl J Med. 2001 Jun 7;344(23):1794; author reply 1795-6. No abstract available.Background
O'Riordan JI, Thompson AJ, Kingsley DP, MacManus DG, Kendall BE, Rudge P, McDonald WI, Miller DH. The prognostic value of brain MRI in clinically isolated syndromes of the CNS. A 10-year follow-up. Brain. 1998 Mar;121 ( Pt 3):495-503. doi: 10.1093/brain/121.3.495.Background
Brex PA, O'Riordan JI, Miszkiel KA, Moseley IF, Thompson AJ, Plant GT, Miller DH. Multisequence MRI in clinically isolated syndromes and the early development of MS. Neurology. 1999 Oct 12;53(6):1184-90. doi: 10.1212/wnl.53.6.1184.
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History
Started
Nov 2001
Main results due
Sept 2007
Finished
Apr 2008