The impact of canine leishmaniosis vaccination with Canileish® in Leishmania infantum infection seroprevalence studies.

Effective vaccines against Leishmania parasites are a goal for the scientific community working with both canine and human leishmaniosis. However, possible side effects of vaccination should also be considered and evaluated, preferably before vaccine licensing and marketing. One of these possible effects is the cross-reaction of vaccine-induced antibodies with standard serological tests for detection of Leishmania infantum infection. Longitudinal studies were performed on the type of humoral profile induced by Brazilian marketed canine leishmaniosis vaccines, but little is known regarding the European situation. In this study, an annual follow-up of 85 CaniLeish® vaccinated dogs and 83 non-vaccinated control dogs was performed. Blood samples were taken for all animals at pre-determined time points: before vaccination; immediately before each one of the two following vaccine doses (at 21 days intervals); and then one, four, six, nine and 12 months after finishing the vaccination course. All samples were tested by an in-house ELISA, using a whole promastigote antigen, for the presence of anti-L. infantum antibodies. Humoral response detectable by the used serological diagnostic method was significantly higher in the vaccine group when compared with the control group (p < 0.01) until one-month post-vaccination. Results show that CaniLeish® vaccine-induced antibodies cross-react with a commonly used serological test for diagnosis of L. infantum natural infection. Implications of this interference are discussed, with special emphasis on a possible negative impact on canine leishmaniosis surveillance studies.