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  • Title: Phase II randomized, placebo-controlled trial of M. vaccae-derived protein (PVAC) for the treatment of psoriasis.
    Author: Netto EM, Takahashi D, de Fátima Paim de Oliveira M, Barbosa P, Ferraz N, Paixão A, Oyafuso LK, Bortoletto C, Matos D, Paixão M, da Silva AO, Badaro R.
    Journal: Vaccine; 2006 Jun 05; 24(23):5056-63. PubMed ID: 16621200.
    Abstract:
    The treatment effect against psoriasis of an antigen (delipidated, deglycolipidated form of M. vaccae-PVAC) was investigated. One hundred and sixty-five patients were enrolled in three arms (50 or 15 microg or placebo), each receiving a total of two intradermal injections (days 0 and 21). At week 12, a 75% decrease in psoriasis area and severity index was similar among the studied groups (13, 9 and 18%, p=0.429). The overall incidence of adverse events was significantly higher in the PVAC treated groups when compared to placebo (98.2, 87.3 and 70.9%; p<0.001) largely due to local reactions that were limited for the most part to grades 1 and 2 in severity and were self-limiting. Despite its overall safety, PVAC was not clearly indicated to be superior to placebo in the treatment of psoriasis in this study.
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