01728nas a2200277   4500000000100000008004100001260001200042653001300054653001600067653001200083653001100095653001200106100001300118700001300131700001000144700001300154700001400167700001100181700001300192700001500205700001300220700001100233245017500244520101700419022001401436       2019                            d  c12/201910aAdjuvant10aImmunologic10aleprosy10aSafety10aVaccine1 aDuthie M1 aFrevol A1 aDay T1 aColer RN1 aVergara J1 aRolf T1 aSagawa Z1 aBeckmann A1 aCasper C1 aReed S00aA phase 1 antigen dose escalation trial to evaluate safety, tolerability and immunogenicity of the leprosy vaccine candidate LepVax (LEP-F1 + GLA-SE) in healthy adults.3 a<p>Healthy United States-based adult volunteers with no history of travel to leprosy-endemic countries were enrolled for the first-in-human evaluation of LepVax (LEP-F1 + GLA-SE). In total 24 volunteers participated in an open-labelclinicaltrial, with 21 receiving three injections of LepVax consisting of either 2 µg or 10 µg recombinantpolyprotein LEP-F1 mixed with 5 µg of the GLA-SE adjuvant formulation. LepVax doses were provided by intramuscular injection on Days 0, 28, and 56, and safety was evaluated for one year following the final injection. LepVaxwas safe and well tolerated at both antigen doses. Immunological analyses indicated that similar LEP-F1-specific antibody and Th1 cytokine secretion (IFN-γ, IL-2, TNF) were induced by each of the antigen doses evaluated within LepVax. This clinicaltrialof the first definedvaccinecandidate for leprosy demonstrates that LepVax is safe and immunogenic in healthy subjects and supports its advancement to testing in leprosy-endemic regions.</p>  a1873-2518