中文摘要：本发明公开了一种疫苗佐剂及其组成，该佐剂能在冷冻、室温及37°C环境下保持稳定，且其成本较低。本发明同时公开了一种治疗和预防大肠杆菌和多种耐药性大肠杆菌等革兰氏阳性菌导致的尿路感染的疫苗及其组成。该发明的特征在于：疫苗的佐剂由磷酸化己酰基双糖或其盐类、柠檬酸盐、琥珀酸盐或10-50mM磷酸缓冲液组成，并将该佐剂与有效剂量的抗原结合；该佐剂稳定性好，能在室温情况下保存60天及以上。
外文摘要：This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.
NOVELTY - Preparing a vaccine comprises providing an adjuvant formulation comprising phosphorylated hexaacyl disaccharide or its salts; and, a citrate, succinate or phosphate buffer at 10-50 mM; and combining the adjuvant formulation with an effective amount of an antigen. The adjuvant formulation is stable for greater than or equal to 60 days at room temperature before its use in the vaccine composition.
USE - The methods are useful for preparing vaccine; for administering vaccine composition to human that has had recurrent urinary tract infections; for treating recurrent urinary tract infections in human; and for inducing the production of antibodies against FimH in human with recurrent urinary tract infections (all claimed) e.g. caused by Gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli.
ADVANTAGE - Provided are adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37 degrees C that can be produced at remarkably low costs.
主权项：(1) a method for administering a vaccine composition to a human that has had recurrent urinary tract infections comprising administering to the human a vaccine composition comprising an adjuvant formulation containing phosphatidylcholine, and phosphorylated hexaacyl disaccharide of formula I or its salts;(2) a method for treating recurrent urinary tract infections in a human comprising administering to the human, a vaccine composition comprising: (i) non-covalent complex of chaperone-like periplasmic protein (FimCH) or truncated adhesin responsible for the binding to D-mannose (FimH), (ii) an adjuvant formulation containing phosphatidylcholine and 20-50 mu g of phosphorylated hexaacyl disaccharide of formula I or its salts; and(3) a method of inducing the production of antibodies against FimH in human with recurrent urinary tract infections, comprising administering a vaccine composition comprising: (i) antigen of FimCH or truncated FimH, and (ii) an adjuvant formulation containing 20-50 mu g of phosphorylated hexaacyl disaccharide of formula I or its salts.
 
申请号：US201615295287
公开/公告号：US2017028060A1
申请日：2016-10-17
公开/公告日：2017-02-02
申请/专利权人：SEQUOIA SCIENCES INC 
发明/设计人：ELDRIDGE GARY [US]; MARTIN STEVEN M
分类号：A61K39/0258; A61K39/39; A61K47/12; A61K9/0019; A61K9/1271; A61K2039/545; A61K2039/55511; A61K2039/55555; A61K2039/55572; A61K2039/575
主分类号：A61K39/108; A61K39/39
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