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Completed

NCT Number: NCT00202410

Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Neurology - University of Rome La Sapienza

Rome, Roma, 00100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bacille of Calmette-Guerin

Biological

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

Placebo

Other

subcutaneous administration of physiologic solution

Primary outcomes

  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 outcomes

  1. volume of T2 lesions

    Time frame: 0 and 6 months

  2. volume of T1 lesions (black holes)

    Time frame: 0 and 6 months

Sponsors and collaborators

Lead sponsor

S. Andrea Hospital

Other

Collaborators

  • Istituto Superiore di Sanità
  • Italian Multiple Sclerosis Foundation

Registry information

Official study 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.

Important dates

Study start
2001
Primary completion
2007
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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