Method for preserving alum adjuvants and alum-adjuvanted vaccines
Inventors
Drew, Jeffrey • Woodward, David • Corteyn, Amanda
Assignees
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Publication Number
US-9101607-B2
Publication Date
2015-08-11
Expiration Date
Abstract
A method for preserving an aluminium-salt adjuvant during freezing or drying comprising freezing or drying an aqueous suspension or solution comprising: (a) an aluminium salt adjuvant; (b) a compound of formula (I) or a physiologically acceptable salt or ester thereof or a compound of formula (II) or a physiologically acceptable salt or ester thereof; and (c) optionally, one or more sugars.
Core Innovation
The invention relates to a method for preserving an aluminium-salt adjuvant during freezing or freeze-drying. The method comprises freezing or freeze-drying an aqueous suspension or solution containing an aluminium salt adjuvant, a compound of formula (I) or a physiologically acceptable salt or ester thereof, and one or more sugars.
The compound of formula (I) is defined by substituent rules in which R1 represents hydrogen or C1-6 alkyl, R4 represents hydrogen, and R2 represents hydrogen, C1-6 alkyl or an —(CH2)2-5NHC(O)(CH2)5-15CH3 group, while R1 and R4 together may form a pyrrolidine ring. The disclosure also specifies physiologically acceptable salts or esters of the compound.
In the described approach, the sugars are included together with the compound of formula (I) and the aluminium-salt adjuvant during the freezing or freeze-drying process, with the stated purpose of reducing structural damage and impaired re-dispersion so that immunogenicity/potency is maintained. The disclosed use context includes antigens, including antigens absorbed on the adjuvant, in vaccine compositions obtainable by the method.
Claims Coverage
Independent claim clm-00001 covers preserving an aluminium-salt adjuvant during freezing or freeze-drying by using an aqueous suspension or solution that includes an aluminium salt adjuvant, a compound of formula (I) or physiologically acceptable salt/ester thereof, and one or more sugars. The inventive features are directed to the specific combination of components and their defined chemical scope, applied to the freezing or freeze-drying preservation step.
Preserving aluminium-salt adjuvant during freezing or freeze-drying
Freezing or freeze-drying an aqueous suspension or solution comprising an aluminium salt adjuvant, a compound of formula (I) or a physiologically acceptable salt or ester thereof, and one or more sugars.
Compound of formula (I) defined by R-group rules for stabilization
Using a compound of formula (I) (or a physiologically acceptable salt or ester thereof) where R1 represents hydrogen or C1-6 alkyl, R4 represents hydrogen or R1 and R4 together with the atoms to which they are attached form a pyrrolidine ring, R2 represents hydrogen, C1-6 alkyl or —(CH2)2-5NHC(O)(CH2)5-15CH3, and R3 represents C1-6 alkyl.
Sugar inclusion in the aqueous suspension or solution
Including one or more sugars in the aqueous suspension or solution together with the aluminium salt adjuvant and the compound of formula (I) during freezing or freeze-drying.
The claim coverage centers on the preservation of an aluminium-salt adjuvant during freezing or freeze-drying by combining the defined compound of formula (I) and one or more sugars in an aqueous suspension or solution.
Stated Advantages
Maintains immunogenicity/potency.
Reduces structural damage and aggregation/crystallization.
Prevents impaired re-dispersion.
Documented Applications
Vaccine compositions obtainable by the method, including cases where at least one antigen is provided absorbed on the adjuvant.
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