Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.

ABSTRACT:

Objective

To evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).

Methods

In a double-blind, placebo-controlled trial, participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI (6 scans). Both groups then entered a preplanned phase with IM interferon-β-1a for 12 months. From month 18 onward, the patients took the disease-modifying therapies (DMTs) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months.

Results

Of 82 randomized subjects, 73 completed the study (33 vaccinated and 40 placebo). During the initial 6 months, the number of cumulative lesions was significantly lower in vaccinated people. The relative risks were 0.541 (95% confidence inte

SUBMITTER: Ristori G 

PROVIDER: S-EPMC3873620 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature