Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

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

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 Intervention Phase
Multiple Sclerosis
Biological: Bacille of Calmette-Guerin
Other: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by S. Andrea Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: November 2001
Study Completion Date: April 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202410

Locations
Italy
Department of Neurology - University of Rome La Sapienza
Rome, Roma, Italy, 00100
Sponsors and Collaborators
S. Andrea Hospital
Multiple Sclerosis Italian Foundation (FISM)
Istituto Superiore di Sanità
Investigators
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

Publications:

Responsible Party: Marco Salvetti, University of Rome "Sapienza"
ClinicalTrials.gov Identifier: NCT00202410     History of Changes
Other Study ID Numbers: NEU - BCG - 01
Study First Received: September 12, 2005
Last Updated: May 18, 2011
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014