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.
Highlights
Canine leishmaniosis (CanL) is an extremely variable and polymorphic disease, caused by progressive uncontrolled infection with the intracellular parasite Leishmania infantum transmitted by the bites of phlebotomine sand flies [1]
We report results of a randomised, double-blinded, controlled 2-season natural-challenge trial with the LiESP/QA-21 vaccine performed in highly endemic areas of the Mediterranean basin
Occasionally associated with pain, was the most remarkable adverse event observed after injection. It was observed in several dogs after the second and third injections (15 and 23 dogs respectively), and resolved spontaneously within 2 to 8 days
Summary
Canine leishmaniosis (CanL) is an extremely variable and polymorphic disease, caused by progressive uncontrolled infection with the intracellular parasite Leishmania infantum (in the Old World, synonym of L. chagasi in the New World) transmitted by the bites of phlebotomine sand flies [1]. It is endemic in the Mediterranean basin, Middle East, Central Asia and Latin America [2] where the dog is considered to be the main reservoir host for zoonotic infection [3]. For these reasons it is important to note that infection is not equal to disease for this parasite [9]
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