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Background  Novel vaccination approaches are needed to prevent leishmaniasis. Live attenuated vaccines are the gold standard for protection against intracellular pathogens such as  Leishmania  and there have been new developments in this field. The nonpathogenic to humans lizard protozoan parasite,  Leishmania  ( L )  tarentolae , has been used effectively as a vaccine platform against visceral leishmaniasis in experimental animal models. Correspondingly, pre-exposure to sand fly saliva or immunization with a salivary protein has been shown to protect mice against cutaneous leishmaniasis.    Methodology/Principal Findings  Here, we tested the efficacy of a novel combination of established protective parasite antigens expressed by  L. tarentolae  together with a sand fly salivary antigen as a vaccine strategy against  L. major  infection. The immunogenicity and protective efficacy of different DNA/Live and Live/Live prime-boost vaccination modalities with live recombinant  L. tarentolae  stably expressing cysteine proteinases (type I and II, CPA/CPB) and PpSP15, an immunogenic salivary protein from  Phlebotomus papatasi , a natural vector of  L. major , were tested both in susceptible BALB/c and resistant C57BL/6 mice. Both humoral and cellular immune responses were assessed before challenge and at 3 and 10 weeks after  Leishmania  infection. In both strains of mice, the strongest protective effect was observed when priming with PpSP15 DNA and boosting with PpSP15 DNA and live recombinant  L. tarentolae  stably expressing cysteine proteinase genes.    Conclusion/Significance  The present study is the first to use a combination of recombinant  L. tarentolae  with a sand fly salivary antigen (PpSP15) and represents a novel promising vaccination approach against leishmaniasis.

plos neglected tropical diseases

Enhanced Protective Efficacy of Nonpathogenic Recombinant Leishmania tarentolae Expressing Cysteine Proteinases Combined with a Sand Fly Salivary Antigen