Evaluation of canine leishmaniosis vaccine CaniLeish® under field conditions in native dog populations from an endemic Mediterranean area–A randomized controlled trial

•No differences were detected in the number or severity of L. infantum active infections between vaccine and control groups.•No severe adverse reactions were observed in the dog population vaccinated with CaniLeish®.•Vaccination induced a significant rise in IFN-γ observable 1-month post-vaccination, which dropped after nine months.•Results fail to support the reported CaniLeish® vaccine efficacy in the prevention of active L. infantum infection.