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2. 发明申请

WO2016144675A1 VACCINE DOSE AND USE THEREOF 审中-公开
标题翻译：疫苗剂量及其用途
公开(公告)号：WO2016144675A1
公开(公告)日：2016-09-15
申请号：PCT/US2016/020597
申请日：2016-03-03
申请人： MEDIMMUNE, LLC
发明人： ESSER, Mark, Thomas , VILLAFANA, Tonya, Luana , FALLOON, Judith , DUBOVSKY, Filip
IPC分类号： A61K39/00 , A61K39/12 , A61K39/155 , A61K39/39 , A61P31/14 , A61P37/04
CPC分类号： A61K39/12 , A61K2039/55566 , A61K2039/55572 , C12N2760/18534
摘要： Disclosed are methods of enhancing respiratory syncytial virus (RSV) immunity in a human subject. The methods encompass administering to a subject a single intramuscular dose of a composition comprising about 20 μg, about 50 μg, 80 μg or about 120 μg RSV soluble F protein. The composition further contains an adjuvant of glucopyranosyl lipid A (GLA) in a squalene-based stable emulsion. The RSV soluble F (sF) protein is amino acids 1-524 of RSV soluble F protein from human strain A2 lacking a transmembrane domain (SEQ ID NO: 1). In some embodiments the subject is human and is at least about 60 years old, or between at least about 60 years old and about 87 years old. In additional embodiments, the method of enhancing RSV immunity in the subject results in enhancing a Th1 biased cellular immune response in the subject, inducing neutralizing antibodies against RSV in the subject, reducing RSV viral titers in the subject, inducing an immune response to RSV in the subject, and/or preventing RSV infection in the subject.
摘要翻译：公开了在人类受试者中增强呼吸道合胞病毒（RSV）免疫的方法。所述方法包括对受试者施用包含约20μg，约50μg，80μg或约120μgRSV可溶性F蛋白的组合物的单次肌内剂量。该组合物还含有一种基于角鲨烯的稳定乳剂中的吡喃葡萄糖基脂质A（GLA）的佐剂。 RSV可溶性F（sF）蛋白是来自缺乏跨膜结构域（SEQ ID NO：1）的人类A2的RSV可溶性F蛋白的氨基酸1-524。在一些实施方案中，受试者是人，至少约60岁，或至少约60岁至约87岁。在另外的实施方案中，增强受试者RSV抗体的方法导致增加受试者中Th1偏向细胞免疫应答，诱导受试者中RSV抗体的中和抗体，减少受试者中的RSV病毒滴度，诱导针对RSV的免疫应答受试者和/或预防受试者的RSV感染。

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