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.

中文翻译：

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一项1期抗原剂量递增试验，用于评估健康成年人中麻风疫苗候选LepVax（LEP-F1 + GLA-SE）的安全性，耐受性和免疫原性。

入选了健康且没有麻风病流行国家历史的美国成年志愿者，进行了LepVax（LEP-F1 + GLA-SE）的人体首次评估。共有24名志愿者参加了开放标签的临床试验，其中21名接受了3次LepVax注射，其中包括2 µg或10 µg重组多蛋白LEP-F1和5 µg GLA-SE佐剂制剂。在第0、28和56天通过肌肉注射提供LepVax剂量，并在最终注射后一年内评估安全性。LepVax在两种抗原剂量下均安全且耐受性良好。免疫学分析表明，在LepVax中评估的每种抗原剂量均可诱导相似的LEP-F1特异性抗体和Th1细胞因子分泌（IFN-γ，IL-2，TNF）。