A vaccine based on purified excreted/secreted antigens of L. infantum has been licensed in Europe since 2011. This vaccine contains a saponin adjuvant.
First vaccination consists of three injections, three weeks apart. Protection is obtained one month after the third injection. Booster injections are given annually.
During 2016, a new vaccine against CanL was licensed in Europe. This new vaccine contains the active substance “protein Q”, a recombinant protein made of five different antigens from L. infantum.
Following the European public assessment report (EPAR), this vaccine does not contain an adjuvant. Primo-vaccination includes only a single injection. Booster injections are given annually.
Both vaccines available in Europe can only be injected to healthy seronegative dogs of six months of age or older. They do not prevent the infection but the progression of the disease and reduce the probability of developing clinical signs.
Licensed anti-Leishmania Vaccines
| Commercial name (manufacturer) | Composition | Availability | Vaccine protocol | Primary outcome | Vaccine efficacy | Diagnostic interference associated w/vaccine | |
| Antigen | Adjuvant | ||||||
| Leishmune® (Zoetis) | Fucose-mannose ligand (FML) | QuilA | Brazil (a) | Three primary vaccination doses (SC), 21-day intervals; one annual booster | Clinical disease | 80% | Detection of vaccinal antibodies with official tests (DPP®, ELISA, IFAT). Antibodies not detected after 45 days of first annual booster by FAST or DAT |
| CaniLeish® (Virbac Santé Animale) | LiESP | QA-21 | Europe; Argentina; Paraguay | Three primary vaccination doses (SC), 21-day intervals; one annual booster | Active infection (b) | 68.4% | Detection of vaccinal antibodies with quantitative tests (ELISA, IFAT). Rare detection of vaccinal antibodies with Speed Leish K™ |
| Leish-Tec® (Hertape Calier Saúde Animal) | A2 | Saponin | Brazil | Three primary vaccination doses (SC), 21-day intervals; one annual booster | Parasite detection | 71.4% | Detection of vaccinal antibodies with official ELISA |
| Letifend® (Laboratorios Leti) | Q-protein | None | Europe | One primary vaccination dose (SC); one annual booster | Clinical disease | 72% | No detection of vaccinal antibodies by quantitative tests (IFAT, ELISA) or rapid tests |
Abbreviations: DAT, direct agglutination test; ELISA, enzyme-linked immunosorbent assay; FAST, fast agglutination screening test; IFAT, immunofluorescence antibody test; LiESP, Leishmania infantum excreted-secreted proteins; SC, subcutaneous.
(a) To date not on the market.
(b) Active infection was defined as the detection of parasite growth in tissue culture from PCR-positive dogs, shortly followed by the elevation of IFAT titers.