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Publication Number
US-10086064-B2
Publication Date
2018-10-02
Expiration Date
Abstract
The present invention relates to the use of an excipient which is a compound of formula (I) or a physiologically acceptable salt or ester thereof: wherein: R1 represents C1-6alkyl; R2 represents hydrogen or C1-6alkyl; and R3 represents C1-6alkyl, for increasing the immunogenicity of an influenza antigen, which use comprises (a) freezing, (b) heat-treating, and/or (c) freeze-drying an aqueous composition comprising the influenza antigen and the excipient.
Core Innovation
The invention relates to increasing the immunogenicity of an influenza antigen by heat-treating an aqueous composition containing the influenza antigen and an excipient that is a compound of formula (I) or a physiologically acceptable salt or ester thereof. The heat-treating is performed at 35°C to 80°C for 1 hour or more, and the immunogenicity of the influenza antigen is increased during the heat-treating.
The influenza antigen is provided in an aqueous composition together with an excipient of formula (I), where the excipient includes dialkylglycine or trialkylglycine compounds such as dimethylglycine and trimethylglycine, or a physiologically acceptable salt or ester of the compound. The formulation concept further includes optional sugars and, optionally, an adjuvant, including an aluminium salt adjuvant.
The document additionally describes that the aqueous composition may be frozen and heat-treated and/or freeze-dried in connection with the excipient, and that these processing conditions lead to an unexpected increase in antigen immunogenicity compared with merely mixing the excipient without thermal processing. The immune response is evaluated in vivo using a haemagglutination inhibition assay (HIA/HAI), including improved titres and an earlier onset of immunity in the described examples.
Claims Coverage
The partial content provides one independent claim covering a method of increasing influenza antigen immunogenicity by heat-treating a specific aqueous composition, with additional dependent claim coverage refining the excipient identity, adding sugars, and optionally including an aluminium salt adjuvant. The independent claim contains the core inventive features that the immunogenicity increase occurs during heat-treating.
Heat-treating aqueous influenza antigen with excipient of formula (I)
Heat-treating an aqueous composition at 35°C to 80°C for 1 hour or more, the aqueous composition comprising the influenza antigen and an excipient which is a compound of formula (I) or a physiologically acceptable salt or ester thereof, wherein the immunogenicity of the influenza antigen is increased during the heat-treating.
Across the provided claim set, the inventive concept is centered on increasing influenza antigen immunogenicity by heat-treating an aqueous influenza antigen formulation containing an excipient of formula (I) (or a physiologically acceptable salt or ester), with dependent features further specifying particular formula (I) excipients (dimethylglycine/trimethylglycine), optionally adding sugars, and optionally including an aluminium salt adjuvant.
Stated Advantages
Increased immunogenicity of the influenza antigen during heat-treating.
Antigen sparing, enabling the same immune response at a much lower antigen dose.
Faster onset of immunity.
Documented Applications
Influenza vaccination formulations using an influenza antigen in an aqueous composition with an excipient of formula (I), optionally with sugars and/or an aluminium salt adjuvant, where thermal processing (heat-treating and optionally freezing/freeeze-drying) increases immunogenicity.
Assessment of vaccine immunogenicity in vivo using a haemagglutination inhibition assay (HIA/HAI) in described mouse examples, showing improved titres and earlier immunity with excipient plus heat treatment.
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