title: A randomised, double-blind, controlled efficacy trial of the LiESP/QA-21 vaccine in naïve dogs exposed to two leishmania infantum transmission seasons.
abstract: Canine leishmaniasis is an important zoonosis caused by uncontrolled infection with Leishmania infantum, where an inappropriate immune response is not only responsible for permitting this intracellular parasite to multiply, but is also responsible for several of the pathological processes seen in this disease. Effective canine vaccines are therefore a highly desirable prevention tool. In this randomised, double-blinded, controlled trial, the efficacy of the LiESP/QA-21 vaccine (CaniLeish, Virbac, France) was assessed by exposing 90 naïve dogs to natural L. infantum infection during 2 consecutive transmission seasons, in two highly endemic areas of the Mediterranean basin. Regular PCR, culture, serological and clinical examinations were performed, and the infection/disease status of the dogs was classified at each examination. The vaccine was well-tolerated, and provided a significant reduction in the risk of progressing to uncontrolled active infection (p = 0.025) or symptomatic disease (p = 0.046), with an efficacy of 68.4% and a protection rate of 92.7%. The probability of becoming PCR positive was similar between groups, but the probability of returning to a PCR negative condition was higher in the vaccinated group (p = 0.04). In conclusion, we confirmed the interest of using this vaccine as part of a comprehensive control program for canine leishmaniasis, and validated the use of a protocol based on regular in-depth assessments over time to assess the efficacy of a canine leishmaniasis vaccine.
authors.affiliation: Department of Veterinary Clinical Sciences, University Federico II, Naples, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Oliva
authors.affiliation: Leishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Nieto
authors.affiliation: Department of Veterinary Clinical Sciences, University Federico II, Naples, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Foglia Manzillo
authors.affiliation: Department of Veterinary Clinical Sciences, University Federico II, Naples, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Cappiello
authors.affiliation: Unit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Fiorentino
authors.affiliation: Unit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Trentina
authors.initials: T
authors.lastname: Di Muccio
authors.affiliation: Unit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Aldo
authors.initials: A
authors.lastname: Scalone
authors.affiliation: Leishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Moreno
authors.affiliation: Leishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Chicharro
authors.affiliation: Leishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
authors.forename: Eugenia
authors.initials: E
authors.lastname: Carrillo
authors.affiliation: Safety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
authors.forename: Therese
authors.initials: T
authors.lastname: Butaud
authors.affiliation: Safety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
authors.forename: Laurie
authors.initials: L
authors.lastname: Guegand
authors.affiliation: Safety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Martin
authors.affiliation: Safety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Cuisinier
authors.affiliation: Medical Department, VIRBAC, Carros, France.
authors.forename: David
authors.initials: D
authors.lastname: McGahie
authors.affiliation: Safety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Gueguen
authors.affiliation: Leishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Cañavate
authors.affiliation: Unit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Gradoni
mesh_terms: D000818:Animals; D004283:Dog Diseases / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D004285:Dogs; D004311:Double-Blind Method; D019353:Endemic Diseases / Q000517:prevention & control / Q000662:veterinary*; D005260:Female; D007303:Insect Vectors / Q000469:parasitology; D007558:Italy; D018314:Leishmania infantum / Q000235:genetics / Q000276:immunology*; D054332:Leishmaniasis Vaccines / Q000008:administration & dosage*; D007898:Leishmaniasis, Visceral / Q000517:prevention & control / Q000635:transmission / Q000662:veterinary*; D008297:Male; D010691:Phlebotomus / Q000469:parasitology; D013030:Spain
chemical_list: D054332:Leishmaniasis Vaccines