Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

May 18, 2011 updated by: S. Andrea Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Roma
      • Rome, Roma, Italy, 00100
        • Department of Neurology - University of Rome La Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of gad-enhancing lesions in T1
Time Frame: baseline and 6 months
baseline and 6 months
number of lesions in T1 and new lesions in T2
Time Frame: baseline and 6 months
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
volume of T2 lesions
Time Frame: 0 and 6 months
0 and 6 months
volume of T1 lesions (black holes)
Time Frame: 0 and 6 months
0 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S. Andrea Hospital

Collaborators

Istituto Superiore di Sanità
Italian Multiple Sclerosis Foundation

Investigators

  • Study Director: Marco Salvetti, Professor, S.Andrea Hospital, University of Rome "La Sapienza"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU - BCG - 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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