Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

NCT00202410 | Completed Phase 2 DMC

• 1 other identifier: NEU - BCG - 01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Tuberculosis vaccine; Therapy

Outcome Measures

Primary Outcomes (2)

• number of gad-enhancing lesions in T1

  baseline and 6 months

• number of lesions in T1 and new lesions in T2

  baseline and 6 months

Secondary Outcomes (2)

• volume of T2 lesions

  0 and 6 months

• volume of T1 lesions (black holes)

  0 and 6 months

Study Arms (2)

physiologic solution

PLACEBO COMPARATOR

subcutaneous administration of physiologic solution

Other: placebo

Bacille Calmette-Guèrin (BCG) Vaccine

EXPERIMENTAL

Anti-Tubercular Vaccination

Biological: Bacille of Calmette-Guerin

Interventions

Bacille of Calmette-Guerin BIOLOGICAL

A single intracutaneous dose of 0.1 mL freeze-dried BCG (1 mg/mL; Berna Institute, Basel).

Bacille Calmette-Guèrin (BCG) Vaccine

placebo OTHER

subcutaneous administration of physiologic solution

physiologic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• S. Andrea Hospital: lead
• Italian Multiple Sclerosis Foundation: collaborator
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

Department of Neurology - University of Rome La Sapienza

Rome, Roma, 00100, Italy

Location

Related Publications (7)

• 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.

  PMID: 10534275 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.

  PMID: 7751856 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.

  PMID: 11172162 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.

  PMID: 11071529 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.

  PMID: 11396455 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.

  PMID: 9549525 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.

  PMID: 10522870 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marco Salvetti, Professor

  S.Andrea Hospital, University of Rome "La Sapienza"

  STUDY DIRECTOR

• Giovanni Ristori, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2001
• Primary Completion: September 1, 2007
• Study Completion: April 1, 2008
• Last Updated: May 19, 2011

Record last verified: 2011-05

Locations

IT (1)