Vaccines comprising aluminum adjuvants and histidine
AssigneeGlaxosmithkline Biologicals SA
InventorsMario Contorni, Massimo Maffei
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Abstract
To improve the stability of vaccines comprising aluminum salt(s), the invention uses the amino acid histidine. This can improve pH stability and adjuvant adsorption and can reduce antigen hydrolysis. Histidine is preferably present during adsorption to the aluminum salt(s). The antigen in the vaccine may be a protein or a saccharide and is preferably from N. meningitidis.
Claims107
A composition comprising an antigen a mixture comprising one or more antigens selected from the group consisting of an outer-membrane vesicle (OMV) preparation from N. meningitidis and a saccharide antigen from N. meningitidis, an aluminium salt, and histidine, said composition further comprising at least about 2.5 mM of free phosphate wherein the one or more antigens are adsorbed to the aluminium salt, wherein the composition does not comprise an antigen from B. pertussis, and wherein the histidine has a concentration from about 1 mM to about 100 mM.
A composition comprising a mixture comprising one or more antigens selected from the group consisting of an outer-membrane vesicle (OMV) preparation from N. meningitidis and a saccharide antigen from N. meningitidis, an aluminium salt, a sodium salt, and histidine, wherein the one or more antigens are adsorbed to the aluminium salt, and wherein the composition does not comprise an antigen from B. pertussis.
A composition comprising a mixture comprising one or more protein antigens from N. meningitidis, an aluminium salt, and histidine, wherein the one or more antigens are adsorbed to the aluminium salt, and wherein the composition does not comprise an antigen from B. pertussis.
A composition comprising a mixture comprising one or more antigens selected from the group consisting of a protein antigen from N. meningitidis;
- an outer-membrane vesicle (OMV) preparation from N. meningitidis and a saccharide antigen from N. meningitidis, an aluminium phosphate salt, and histidine, wherein the one or more antigens are adsorbed to the aluminium phosphate salt, and wherein the composition does not comprise an antigen from B. pertussis.
A formulation which stabilizes a N. meningitidis 741 protein composition, the formulation comprising (i) a pH buffered solution comprising histidine (ii) a detergent, and (iii) a N. meningitidis 741 protein.
A composition comprising a mixture comprising one or more protein antigens from N. meningitidis, an aluminium salt, and histidine, wherein the composition does not comprise an H. influenzae saccharide antigen.
A composition comprising a mixture comprising one or more protein antigens from N. menigitidis, an aluminium salt, and histidine, wherein the one or more protein antigens are adsorbed to the aluminium salt and wherein the histidine has a concentration from about 1 mM to about 100 mM.
A composition comprising a mixture comprising two protein antigens from N. meningitidis, an aluminium hydroxyphosphate salt, histidine, and a sodium chloride salt, wherein the two protein antigens are adsorbed to the aluminium hydroxyphosphate salt, wherein the histidine has a concentration from about 5 mM to about 10 mM L-histidine, wherein the composition has a pH between 6 and 7, wherein the Al+++ of the alumninium hydroxyphosphate has a concentration of at least 10 μg/mL, wherein the two protein antigens are each present at a concentration of at least 1 μg/mL, wherein the composition comprises no viral antigens, wherein the composition does not comprise a preservative, and wherein the composition does not comprise an H. influenzae saccharide antigen or an antigen from B. pertussis.
Dependencies are inferred from the claim text.