Phase II randomized, placebo-controlled trial of M. vaccae-derived protein (PVAC) for the treatment of psoriasis.

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.

journal_name

Vaccine

journal_title

Vaccine

authors

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

doi

10.1016/j.vaccine.2006.03.047

subject

Has Abstract

pub_date

2006-06-05 00:00:00

pages

5056-63

issue

23

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(06)00353-7

journal_volume

24

pub_type

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