Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: placebo; Biological: Bacille of Calmette-Guerin

• Registration Number: NCT00202410
• Lead Sponsor: S. Andrea Hospital

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.

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 Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-09
• Study Completion: 2008-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physiologic solution	placebo	subcutaneous administration of physiologic solution
Bacille Calmette-Guèrin (BCG) Vaccine	Bacille of Calmette-Guerin	Anti-Tubercular Vaccination

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
volume of T2 lesions	0 and 6 months
volume of T1 lesions (black holes)	0 and 6 months

Trial Locations

Locations (1)

Department of Neurology - University of Rome La Sapienza; 🇮🇹 Rome, Roma, Italy