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1. 发明申请

WO2023044388A1 VACCINE COMPOSITIONS 审中-公开
公开(公告)号：WO2023044388A1
公开(公告)日：2023-03-23
申请号：PCT/US2022/076494
申请日：2022-09-15
申请人： EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.
发明人： LATA, James Paul , WARFIELD, Kelly Lyn , LACY, Michael Joseph , LOOK, Jee Loon , RUIZ, Christian Fernando
IPC分类号： A61K39/12 , A61P31/16
摘要： The present invention relates to a vaccine composition comprising an influenza Type A hemagglutinin stabilized stem nanoparticle (HA-ss-np); an aluminum hydroxide; a synthetic oligodeoxynucleotide adjuvant containing at least one CpG motif (CpG ODN); and a phosphate salt, wherein the HA-ss-np is not substantially adsorbed to the aluminum hydroxide, and wherein at least a portion of the CpG ODN is adsorbed to the aluminum hydroxide in the composition. The present disclosure also provides a method of inducing an immunological response against an influenza virus in a subject in need thereof, comprising administering an immunologically effective amount of the vaccine composition described herein. The present disclosure further provides a method of inducing an immunological response against an influenza virus in a subject in need thereof, comprising administering a dose of about 20 μg to about 300 μg of an HA-ss-np in a vaccine composition, wherein the vaccine composition further comprises an aluminum hydroxide; CpG ODN; and a phosphate salt, and wherein the HA-ss-np is not substantially adsorbed to the aluminum hydroxide, and wherein at least a portion of the CpG ODN is adsorbed to the aluminum hydroxide. Also provided herein is a method of producing a vaccine composition, comprising combining HA-ss-np with an adjuvant mixture, wherein the adjuvant mixture comprises a diluent solution comprising a phosphate salt; aluminum hydroxide; and CpG ODN, wherein the adjuvant mixture comprises CpG ODN-adsorbed aluminum hydroxide, and wherein the HA-ss-np is not substantially adsorbed to the aluminum hydroxide.

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