Immunoprophylaxis pharmacotherapy against canine leishmaniosis: A systematic review and meta-analysis on the efficacy of vaccines approved in European Union.

Leishmania (L.) infantum is a vector-borne parasite currently endemic in several Southern countries of European Union (EU), and dogs represent the main reservoir and hosts. Data from clinical trials are inconsistent with respect to the efficacy of vaccination against L. infantum infection. Therefore, a quantitative synthesis via pairwise meta-analysis was performed in agreement with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) to increase the strength of evidence and assess the real efficacy profile of vaccines against L. infantum currently approved in EU. Data obtained from 1,394 dogs were extracted from 10 studies. The overall analysis indicated that vaccination is significantly effective in protecting against L. infantum infection (RR 0.40, 95%CI 0.23-0.72; I 70%; P < 0.01 vs. negative controls). The subset analysis performed by excluding the effect modifiers and by considering only the studies that assessed the efficacy of vaccines currently available in EU, indicated that CaniLeish® (RR 0.38, 95%CI 0.20-0.72; I 0%), but not Letifend® (RR 0.43, 95%CI 0.15-1.22; I 37%), significantly protected against L. infantum infection when compared to negative controls (P < 0.05). The number needed to treat analysis showed that 3.77 (95%CI 2.59-6.94) and 10.99 (95%CI 8.28-16.34) dogs had to be treated with CaniLeish® and Letifend®, respectively, to prevent one case of infection compared to negative controls. Vaccination is effective in protecting against the risk L. infantum infection, but further studies are needed to assess whether CaniLeish® and Letifend® are characterized by similar efficacy profile.