Improvement in psoriasis after intradermal administration of delipidated, deglycolipidated Mycobacterium vaccae (PVAC): results of an open-label trial.
The aim of new treatments for psoriasis is to induce extended remissions with fewer side-effects. Previous studies suggest that Mycobacterium vaccae, a harmless organism prepared as a heat-killed suspension, may induce periods of remission in some psoriasis patients after intradermal administration. To assess a more potent derivative of M. vaccae, we conducted an open-label study in which 20 patients with moderate to severe psoriasis (Psoriasis Area and Severity Index of 12-35) received two intradermal inoculations of heat-killed, delipidated, deglycolipidated M. vaccae (DD-MVAC or 'PVAC') in lesion-free deltoid skin, separated by a period of 3 weeks. Twelve weeks after the injections, 13 out of 20 patients (65%) showed marked improvement in the PASI score (> 50% reduction), three were unchanged (< 25% reduction), three had worsened (> 5% increase), and one was withdrawn from the trial because of an exfoliative flare. At 24 weeks, 13 out of 19 patients continued to show > 50% improvement that, in some, lasted for 6 months or longer. Patients classified as good responders at 12 or 24 weeks were then offered additional PVAC injections after 24 weeks if the PASI reached 8 or higher. Intra-dermal administration of PVAC was safe, well tolerated, and induced clinically significant improvement in many psoriasis patients. A randomized, double-blind, controlled study is warranted.
Balagon
M V
MV
Leonard Wood Memorial Center for Leprosy Research (American Leprosy Foundation), Cebu City, Philippines.
Tan
P L
PL
Prestidge
R
R
Cellona
R V
RV
Abalos
R M
RM
Tan
E V
EV
Walsh
G P
GP
Watson
J D
JD
Walsh
D S
DS
D000293:Adolescent; D000328:Adult; D001428:Bacterial Vaccines / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016233:Immunotherapy, Active / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000276:immunology*; D011565:Psoriasis / Q000628:therapy*; D012720:Severity of Illness Index; D015164:Vaccines, Inactivated / Q000627:therapeutic use
D001428:Bacterial Vaccines; D015164:Vaccines, Inactivated