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

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 15μg or placebo), each receiving a total of two intradermal injections (days 0 and 21). At week 12, a 7...

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Veröffentlicht in:	Vaccine 2006-06, Vol.24 (23), p.5056-5063
Hauptverfasser:	Netto, Eduardo Martins, Takahashi, Denise, de Fátima Paim de Oliveira, Maria, Barbosa, Paulo, Ferraz, Neide, Paixão, Ariene, Oyafuso, Luiza Keiko, Bortoletto, Cecília, Matos, Denise, Paixão, Maurício, da Silva, Anete Olivieri Pessoa, Badaro, Roberto
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adult Aged Antigens, Bacterial - genetics Antigens, Bacterial - therapeutic use Applied microbiology Bacterial Vaccines - adverse effects Bacterial Vaccines - therapeutic use Biological and medical sciences Female Fundamental and applied biological sciences. Psychology Humans Immunotherapy Immunotherapy, Active Male Microbiology Middle Aged Mycobacterium - genetics Mycobacterium - immunology Mycobacterium vaccae Placebo Placebos Plaque psoriasis Psoriasis - drug therapy PVAC Treatment Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Inactivated - adverse effects Vaccines, Inactivated - therapeutic use
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Zusammenfassung:	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 15μg 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
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2006.03.047