Immunochemotherapy for cutaneous leishmaniasis: a controlled trial using killed Leishmania (Leishmania) amazonensis vaccine plus antimonial.
BACKGROUND
Leishmaniasis is endemic in 88 countries in the world, and 350 million individuals are at risk of acquiring the disease. Treatment for American cutaneous leishmaniasis (ACL) is long, expensive, and associated with important side-effects.


METHODS
In this double-blind, placebo-controlled study, we treated 102 patients with ACL using either a combination of a single-strain Leishmania amazonensis killed promastigote vaccine plus a half dose of meglumine antimoniate, or placebo plus the same half dose regimen of meglumine antimoniate, in 10-day series followed by 10-day intervals.


RESULTS
Of the 47 patients in the experimental arm, 47 (100%) were cured after four series of treatment, compared to four of 49 (8.2%) in the control group (P < 0.0001). Six patients were lost to follow-up.


CONCLUSIONS
The combination of a single-strain Leishmania (Leishmania) amazonensis killed promastigote vaccine with a half dose regimen of antimonial is highly effective for the treatment of ACL.
Machado-Pinto
Jackson
J
Department of Dermatology, Santa Casa Hospital, Federal University of Minas Gerais, Belo Horizonte, Brazil. jackpin@gold.com.br
Pinto
Jorge
J
da Costa
Carlos Alberto
CA
Genaro
Odair
O
Marques
Marcos José
MJ
Modabber
Farrokh
F
Mayrink
Wilson
W
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016233:Immunotherapy, Active; D007891:Leishmania / Q000276:immunology*; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy* / Q000276:immunology*; D008297:Male; D008536:Meglumine / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*
D009942:Organometallic Compounds; D008536:Meglumine; D000077485:Meglumine Antimoniate