Table 1.
Canine vaccines for visceral leishmaniasis assayed in field trials.
| Vaccine | Composition | Licensed* | VE (%)** | Results obtained |
|---|---|---|---|---|
| Leishvacin | L. braziliensis lysate + BCG | − | − | Protective in kennel assay but failed in Phase III assay in Brazil |
| ALM | Aluminum hydroxide-L. major | − | 69.3 | Protective against natural infection by L. infantum in Iran |
| Lyophilized protein preparation | L. infantum semi-purified proteins (94–67 kDa) | − | − | Protective in mice assays but not in field trial in France |
| Leishmune® | L. donovani FML antigen and QS21 and deacylated saponins of Quillaja saponaria | + | 76–80 | Immunogenic, immunoprophylactic, and immunotherapeutic in mice and hamsters Long-lasting protection against infection, severe disease, and deaths of ZVL in dog field trials in Brazil |
| Safe and well tolerated | ||||
| Vaccinated dogs do not expose parasites and are negative in xenodiagnosis | ||||
| The generated dog antibodies block the transmission of the disease by sand flies | ||||
| With double saponin concentration is therapeutic against naturally or experimentally acquired ZVL. In immunochemotherapy promotes the sterile cure | ||||
| Leishmune® enhances the levels of IFN-γ, NO, and anti-L. chagasi IgG2, the early and persistent activation of neutrophils and monocytes | ||||
| Leishmune® increases the CD8 + T-cells expressing IFN-γ and sustain or increases the proportions of CD4+ and CD21-B lymphocytes | ||||
| Leishmune® vaccination does not interfere in epidemiological serological control tests | ||||
| A decrease in human and canine incidence and in canine seroprevalence of ZVL was observed after dog vaccination in two Brazilian towns | ||||
| LiESAP | 54 kDa excreted protein of L. infantum + MDP | − | 92% | Long-lasting protection against, infection but not against deaths or severe disease by ZVL, in a field assay performed in France at a lower infective pressure endemic region |
| Vaccinated dogs showed a significant leishmanicidal effect of macrophages due to an IFN-γ dependent activation; a NO-mediated apoptosis of intracellular amastigotes, a strong and long-lasting cell-mediated immunity revealed by positive IDR, an anti-leishmanial activity of monocytes, and by the in vitro activities of the anti-LiESAp antibodies | ||||
| A similar antigen to LiESAp + QA21 saponin was licensed in Europe in 2011 with undisclosed results of field assays |
*For prophylaxis against canine visceral leishmaniasis.
**VE, vaccine efficacy in Phase III trials.