An adjuvant system (AS37) has been developed containing a synthetic toll-like receptor agonist (TLR7a). We conducted a phase I randomized, observer-blind, dose-escalation study to assess the safety and immunogenicity of an investigational AS37-adjuvanted meningococcus C (MenC) conjugate vaccine in healthy adults (NCT02639351). A control group received a licensed MenC conjugate alum-adjuvanted vaccine. Eighty participants were randomized to receive one dose of control or investigational vaccine containing AS37 (TLR7a dose 12.5, 25, 50, 100 μg). All vaccines were well tolerated, apart from in the TLR7a 100 μg dose group, which had three reports (18.8%) of severe systemic adverse events. Four weeks after vaccination, human complement serum bactericidal assay seroresponse rates against MenC were 56-81% in all groups, and ELISA seroresponses were ≥81% for all AS37-adjuvanted vaccine groups (100% in 50 and 100 μg dose groups) and 88% in the control group. Antibody responses were maintained at six months after vaccination.

中文翻译：

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TLR7激动剂吸附在氢氧化铝（AS37）上的佐剂作用：AS37佐剂脑膜炎球菌C结合疫苗的I期随机，剂量递增研究。

已经开发了包含合成的toll样受体激动剂（TLR7a）的佐剂系统（AS37）。我们进行了一项I期随机，观察者盲目，剂量递增的研究，以评估健康成年人中研究性AS37佐剂性脑膜炎球菌C（MenC）结合疫苗的安全性和免疫原性。对照组接受许可的MenC缀合物明矾佐剂疫苗。80名参与者被随机分配接受一剂含有AS37的对照或研究性疫苗（TLR7a剂量分别为12.5、25、50、100μg）。除TLR7a 100μg剂量组外，所有疫苗均具有良好的耐受性，该组有3例报告（18.8％）的严重全身性不良事件。接种疫苗后四周，所有组中针对MenC的人补体血清杀菌试验血清反应率均为56-81％，所有AS37辅助疫苗组（50和100μg剂量组中100％）和对照组中88％的血清和ELISA血清反应均≥81％。疫苗接种后六个月维持抗体应答。