We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202410
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 19, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Bacille of Calmette-Guerin Other: placebo Phase 2 Phase 3

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study.
Study Start Date : November 2001
Primary Completion Date : September 2007
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: physiologic solution
subcutaneous administration of physiologic solution
Other: placebo
subcutaneous administration of physiologic solution
Experimental: Bacille Calmette-Guèrin (BCG) Vaccine
Anti-Tubercular Vaccination
Biological: Bacille of Calmette-Guerin
A single intracutaneous dose of 0.1 mL freeze-dried BCG (1 mg/mL; Berna Institute, Basel).

Outcome Measures

Primary Outcome Measures :
  1. number of gad-enhancing lesions in T1 [ Time Frame: baseline and 6 months ]
  2. number of lesions in T1 and new lesions in T2 [ Time Frame: baseline and 6 months ]

Secondary Outcome Measures :
  1. volume of T2 lesions [ Time Frame: 0 and 6 months ]
  2. volume of T1 lesions (black holes) [ Time Frame: 0 and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202410

Department of Neurology - University of Rome La Sapienza
Rome, Roma, Italy, 00100
Sponsors and Collaborators
S. Andrea Hospital
Italian Multiple Sclerosis Foundation
Istituto Superiore di Sanità
Study Director: Marco Salvetti, Professor S.Andrea Hospital, University of Rome "La Sapienza"
Principal Investigator: Giovanni Ristori, MD University of Roma La Sapienza
More Information

Responsible Party: Marco Salvetti, University of Rome "Sapienza"
ClinicalTrials.gov Identifier: NCT00202410     History of Changes
Other Study ID Numbers: NEU - BCG - 01
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

Keywords provided by S. Andrea Hospital:
Multiple Sclerosis
Tuberculosis vaccine

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antitubercular Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents