title: Field trial of a vaccine against New World cutaneous leishmaniasis in an at-risk child population: safety, immunogenicity, and efficacy during the first 12 months of follow-up.
abstract: The safety, immunogenicity, and efficacy of a vaccine against cutaneous leishmaniasis in rural Ecuadorian children was assessed in a randomized, controlled, double-blinded study. Vaccine group subjects received 2 intradermal doses of a whole, killed promastigote vaccine cocktail plus bacille Calmette-Guérin (BCG) adjuvant. Control subjects got 2 doses of BCG only. The subjects who received both vaccination doses, 438 in the vaccine group (79.3%) and 406 in the control group (83.4%), were followed for 12 months. No serious adverse side effects were identified in either group. Significantly more vaccine group subjects than controls converted to a positive Montenegro skin test (85.1% vs. 20.1%; chi2 = 279; P < .001). The incidence of cutaneous leishmaniasis was significantly reduced in the vaccine compared with the control group (2.1% vs. 7.6%; chi2 = 8.95; P < .003). The protective efficacy of the vaccine was 72.9% (95% confidence interval = 36.1%-88.5%).
authors.affiliation: Immunology Research Laboratory, and Graduate School of Basic Medical Sciences, College of Medicine, Central University of Ecuador, Quito.
authors.forename: R X
authors.initials: RX
authors.lastname: Armijos
authors.forename: M M
authors.initials: MM
authors.lastname: Weigel
authors.forename: H
authors.initials: H
authors.lastname: Aviles
authors.forename: R
authors.initials: R
authors.lastname: Maldonado
authors.forename: J
authors.initials: J
authors.lastname: Racines
mesh_terms: D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004484:Ecuador; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D007271:Injections, Intradermal; D016773:Leishmaniasis, Cutaneous / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control*; D008297:Male; D009163:Mycobacterium bovis; D009752:Nutritional Status; D016052:Protozoan Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D012424:Rural Population; D012882:Skin Tests
chemical_list: D016052:Protozoan Vaccines