Abstract
The prevention of canine leishmaniosis in healthy dogs requires a multimodal approach combining repellents with an effective vaccine. A vaccine that modulates the cell-mediated immune response against the protozoan has been available in Europe since 2012 (CaniLeish®, Virbac, France). The aim of the present study was to monitor dogs vaccinated with CaniLeish® to examine the kinetics of the antibody response and the safety and tolerance of CaniLeish®. Dogs vaccinated with CaniLeish® were monitored for 12 months. In follow-up visits at baseline (primovaccination or annual booster) (Visit 1, V1), and 1 (V2), 4 (V3), 8 (V4) and 12 (V5) months later, we examined antibody response kinetics using two serology techniques (IFAT and Speed Leish K™). Tolerance to CaniLeish® and its safety were also monitored. Anti-L. infantum IgG antibodies were determined in 242 dogs (125 dogs after primovaccination (Group P) and 117 dogs after booster vaccination (Group B). In addition, 46, 22 and 19 dogs were followed for 2, 3 and 4 years, respectively. At baseline, 100% of dogs in Group P returned negative IFAT and Speed Leish K™ test results while 9.4% (11/117) in Group B tested IFAT positive though Speed Leish K™ negative. In subsequent visits, seropositivity was detected by IFAT in 31.2% (Group P) and 41% (Group B) of the dogs in V2; 16.8% (Group P) and 10.2% (Group B) in V3; 6.4% (Group P) and 8.5% (Group B) in V4; and 3.2% (Group P) and 5.9% (Group B) in V5. All dogs tested Speed Leish K™ negative except two, in which it was later confirmed by molecular testing that they were not infected. Adverse events that could be associated with the vaccine were detected in 20 out of 314 dogs (6.4%). The good clinical status of all dogs was confirmed in an exhaustive clinical exam and haemato-biochemical profile. The Canileish® vaccine was well-tolerated with exceptions that did not appear to be related to age, sex, race or size of vaccinated dogs. Anti-L. infantum antibodies were detected by IFAT in 31.9–40.3% of the dogs 1 month after vaccination, and these antibodies could still be detected in 3.2% of the dogs 1 year later. This means that veterinarians need to use other tools (eg. PCR) to correctly diagnose seropositive dogs.


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Acknowledgements
The authors thank the owners of the dogs and the participating veterinarians for their collaboration. VacVets or participating veterinary clinics (VV) were CV Sagrada Familia (Barcelona), CV Cruz Verde (Ciudad Real), CV Pozoblanco (Córdoba), CV Los Tendales (Galicia), CV Las Platerias (Guadalajara), Policlínica Veterinaria Oza (Huesca), CV San Jorge (Ibiza), CV Alpedrete, CV Don Felix, CV Guinzo de Lima, HCVC-UCM, CV 2000 and CV Momo (Madrid), CV Torreblanca (Málaga), CV Alcayna (Murcia), HV Guadiamar (Sevilla), CV Albekas-Gran Danés and Hosclivet (Toledo), CV Caroig, HV Constitución, Mediterrani Veterinaris and (Valencia), CV Miralbueno-Guillén Veterinarios (Zaragoza).
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This paper was funded in part by VIRBAC laboratories.
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GM conceived and coordinated the study, participated in its design and drafted and finalised the manuscript. AM participated in the diagnostic assays, data elaboration, statistical analysis, drafted the first version of the manuscript and finalised the manuscript. RC carried out the molecular procedures and helped with the manuscript draft. VM and RG collaborated with data collection and contacted veterinary clinics. MP participated in the physical exam, blood sample collection and clinical follow-up of the included dogs. KDM and CHN collaborated in the design of the study. VV was responsible for the vaccination and follow-up of the dogs. All authors read and approved the final manuscript.
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Montoya, A., Checa, R., Marino, V. et al. Antibodies elicited by the CaniLeish® vaccine: long-term clinical follow-up study of dogs in Spain. Parasitol Res 120, 1471–1479 (2021). https://doi.org/10.1007/s00436-021-07091-1
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DOI: https://doi.org/10.1007/s00436-021-07091-1


