title: Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia.
abstract: We report the results of a double-blind, randomized, placebo-controlled clinical trial of a killed whole-cell Leishmania amazonensis candidate vaccine against American cutaneous leishmaniasis (CL) in Colombia. The trial subjects were 2597 healthy volunteers with negative leishmanin skin test (LST) selected from rural Colombian soldiers who were going to patrol endemic areas. They were randomized to receive either three doses of vaccine (n=1295) or placebo (n=1302) given at 20-day intervals. An active and passive case detection system was established to follow-up volunteers for 1 year after vaccination. Safety and efficacy of the vaccine were determined by comparing local and systemic adverse reactions after each dose and the incidence of parasitologically confirmed CL. In the vaccine and placebo groups 101 (7.7%) and 88 (6.8%) volunteers developed CL respectively. The vaccine was shown to be safe but offered no protection against CL caused by L. panamensis in the proposed vaccination schedule.
authors.affiliation: Programa de Estudio y Control de Enfermedades Tropicales, PECET, Universidad de Antioquia, Apartado Aéreo 1226, Calle 62 # 52-59 Medellín, Colombia. idvelez@udea.edu.co
authors.forename: Iván D
authors.initials: ID
authors.lastname: Vélez
authors.forename: Katherine
authors.initials: K
authors.lastname: Gilchrist
authors.forename: María P
authors.initials: MP
authors.lastname: Arbelaez
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Rojas
authors.forename: Juan A
authors.initials: JA
authors.lastname: Puerta
authors.forename: Carlos M F
authors.initials: CM
authors.lastname: Antunes
authors.forename: Fabio
authors.initials: F
authors.lastname: Zicker
authors.forename: Farrokh
authors.initials: F
authors.lastname: Modabber
mesh_terms: D000328:Adult; D000818:Animals; D003105:Colombia / Q000453:epidemiology; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D007891:Leishmania / Q000276:immunology*; D016773:Leishmaniasis, Cutaneous / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D008889:Military Personnel; D016052:Protozoan Vaccines / Q000627:therapeutic use*; D012423:Rural Health; D016019:Survival Analysis; D017211:Treatment Failure; D015164:Vaccines, Inactivated / Q000627:therapeutic use
chemical_list: D016052:Protozoan Vaccines; D015164:Vaccines, Inactivated