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Background  Recombinant KSAC and L110f are promising  Leishmania  vaccine candidates. Both antigens formulated in stable emulsions (SE) with the natural TLR4 agonist MPL® and L110f with the synthetic TLR4 agonist GLA in SE protected BALB/c mice against  L. major  infection following needle challenge. Considering the virulence of vector-transmitted  Leishmania  infections, we vaccinated BALB/c mice with either KSAC+GLA-SE or L110f+GLA-SE to assess protection against  L. major  transmitted via its vector  Phlebotomus duboscqi .    Methods  Mice receiving the KSAC or L110f vaccines were challenged by needle or  L. major -infected sand flies. Weekly disease progression and terminal parasite loads were determined. Immunological responses to KSAC, L110f, or soluble  Leishmania  antigen (SLA) were assessed throughout vaccination, three and twelve weeks after immunization, and one week post-challenge.    Results  Following sand fly challenge, KSAC-vaccinated mice were protected while L110f-vaccinated animals showed partial protection. Protection correlated with the ability of SLA to induce IFN-γ-producing CD4 + CD62L low CCR7 low  effector memory T cells pre- and post-sand fly challenge.    Conclusions  This study demonstrates the protective efficacy of KSAC+GLA-SE against sand fly challenge; the importance of vector-transmitted challenge in evaluating vaccine candidates against  Leishmania  infection; and the necessity of a rapid potent Th1 response against  Leishmania  to attain true protection.

KSAC, a Defined Leishmania Antigen, plus Adjuvant Protects against the Virulence of L. major Transmitted by Its Natural Vector Phlebotomus duboscqi