Tendler Miriam, Almeida Marília S, Vilar Monica M, Pinto Patrícia M, Limaverde-Sousa Gabriel
FIOCRUZ-Instituto Oswaldo Cruz, Laboratório de Esquistossomose Experimental, Av. Brasil, 4365, Manguinhos, Rio de Janeiro 21045-900, Brazil.
Trop Med Infect Dis. 2018 Nov 21;3(4):121. doi: 10.3390/tropicalmed3040121.
Schistosomiasis, a disease historically associated with poverty, lack of sanitation and social inequality, is a chronic, debilitating parasitic infection, affecting hundreds of millions of people in endemic countries. Although chemotherapy is capable of reducing morbidity in humans, rapid re-infection demonstrates that the impact of drug treatment on transmission control or disease elimination is marginal. In addition, despite more than two decades of well-executed control activities based on large-scale chemotherapy, the disease is expanding in many areas including Brazil. The development of the Sm14/GLA-SE schistosomiasis vaccine is an emblematic, open knowledge innovation that has successfully completed phase I and phase IIa clinical trials, with Phase II/III trials underway in the African continent, to be followed by further trials in Brazil. The discovery and experimental phases of the development of this vaccine gathered a robust collection of data that strongly supports the ongoing clinical phase. This paper reviews the development of the Sm14 vaccine, formulated with glucopyranosyl lipid A (GLA-SE), from the initial experimental developments to clinical trials including the current status of phase II studies.
血吸虫病是一种历史上与贫困、缺乏卫生设施和社会不平等相关的疾病，是一种慢性、使人衰弱的寄生虫感染，在流行国家影响着数亿人。尽管化疗能够降低人类的发病率，但快速再次感染表明药物治疗对传播控制或疾病消除的影响微乎其微。此外，尽管基于大规模化疗进行了二十多年执行良好的控制活动，但该疾病仍在包括巴西在内的许多地区蔓延。Sm14/GLA-SE血吸虫病疫苗的研发是一项具有代表性的开放知识创新成果，已成功完成I期和IIa期临床试验，目前正在非洲大陆进行II/III期试验，随后将在巴西进行进一步试验。该疫苗研发的发现和实验阶段收集了大量数据，有力地支持了正在进行的临床阶段。本文回顾了用吡喃葡萄糖基脂质A（GLA-SE）配制的Sm14疫苗从最初的实验开发到临床试验（包括II期研究的现状）的研发过程。
