A Randomised, Double- Blind, Controlled Efficacy Trial of the LiESP/QA-21 Vaccine in Naive Dogs Exposed to Two Leishmania infantum Transmission Seasons

作者:Oliva Gaetano*; Nieto Javier; Manzillo Valentina Foglia; Cappiello Silvia; Fiorentino Eleonora; Di Muccio Trentina; Scalone Aldo; Moreno Javier; Chicharro Carmen; Carrillo Eugenia; Butaud Therese; Guegand Laurie; Martin Virginie; Cuisinier Anne Marie; McGahie David; Gueguen Sylvie; Canavate Carmen; Gradoni Luigi
来源:PLoS Neglected Tropical Diseases, 2014, 8(10): e3213.
DOI:10.1371/journal.pntd.0003213

摘要

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 naive 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.

  • 出版日期2014-10