Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
Multiple Sclerosis Italian Foundation (FISM)
Istituto Superiore di Sanità (ISS)
Information provided by:
S. Andrea Hospital
ClinicalTrials.gov Identifier:
NCT00202410
First received: September 12, 2005
Last updated: May 18, 2011
Last verified: May 2011

September 12, 2005
May 18, 2011
November 2001
September 2007   (final data collection date for primary outcome measure)
  • number of gad-enhancing lesions in T1 [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • number of lesions in T1 and new lesions in T2 [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • number of gad-enhancing lesions in T1 at 1,2,3,4,5,6 months
  • number of lesions in T1 and new lesions in T2 at 1,2,3,4,5,6 months
Complete list of historical versions of study NCT00202410 on ClinicalTrials.gov Archive Site
  • volume of T2 lesions [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
  • volume of T1 lesions (black holes) [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
  • volume of T2 lesions at 0 and 6 months
  • volume of T1 lesions (black holes) at 0 and 6 months
Not Provided
Not Provided
 
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.

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.

Vaccination with the Tuberculosis Mycobacterium has proved to be effective in the animal model of multiple sclerosis, experimental allergic encephalitis.

In a study of phase I-II our group has demonstrated the safety of this therapy together with preliminary evidence.

The study includes 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.

Study design 100 randomized patients (i.e. randomly assigned) to be included either in a group of 50 patients undergoing therapy or to a group of 50 patients receiving placebo.

Patients are followed up with monthly contrast MRI for 6 months. At the end of the six months the disease activity in the group of treated patients is benchmarked with the disease activity of the group of patients receiving placebo.

Safety is granted by the extremely wide diffusion of this kind of vaccination worldwide and by the previous study in patients affected by multiple sclerosis.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Multiple Sclerosis
  • Biological: Bacille of Calmette-Guerin
    A single intracutaneous dose of 0.1 mL freeze-dried BCG (1 mg/mL; Berna Institute, Basel).
  • Other: placebo
    subcutaneous administration of physiologic solution
  • Placebo Comparator: physiologic solution
    subcutaneous administration of physiologic solution
    Intervention: Other: placebo
  • Experimental: Bacille Calmette-Guèrin (BCG) Vaccine
    Anti-Tubercular Vaccination
    Intervention: Biological: Bacille of Calmette-Guerin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00202410
NEU - BCG - 01
Yes
Marco Salvetti, University of Rome "Sapienza"
S. Andrea Hospital
  • Multiple Sclerosis Italian Foundation (FISM)
  • Istituto Superiore di Sanità (ISS)
Study Director: Marco Salvetti, Professor S.Andrea Hospital, University of Rome "La Sapienza"
Principal Investigator: Giovanni Ristori, MD University of Roma La Sapienza
S. Andrea Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP