Compositions of vaccines and adjuvants and methods for the treatment of urinary tract infections
Inventors
Eldridge, Gary • Martin, Steven M.
Assignees
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Publication Number
US-9415097-B2
Publication Date
2016-08-16
Expiration Date
Abstract
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.
Core Innovation
The document describes a composition comprising the compound of Formula I, or pharmaceutically acceptable salts thereof, together with a citrate or succinate buffer from about 10 mM to about 50 mM. The composition is substantially free of saline and is stable when exposed to room temperature for 60 or more days, with related embodiments describing stability for at least 6 months.
In additional embodiments, the stabilized composition includes low-salinity constraints, a pH range of about 4.5 to about 6.5, and an aqueous buffered suspension with a mean particle size of 150 nanometers or less. The composition can further include phosphatidylcholine, defined by a phosphatidylcholine-to-compound of Formula I molar ratio and, in further embodiments, selected from specific phosphatidylcholine species or mixtures thereof.
The document also describes vaccine compositions in which an effective amount of an antigen is combined with an adjuvant comprising an effective amount of the compound of Formula I and citrate or succinate buffer from 15 mM to about 50 mM. In vaccine embodiments, the antigen is identified as FimCH, and the overall context links these compositions to urinary tract infection prevention or treatment approaches based on inducing anti-FimH antibodies.
Claims Coverage
The independent claims cover four composition-level embodiments and one vaccine composition embodiment. The main inventive features are a specific buffered system containing Formula I under substantially free of saline conditions with room-temperature stability requirements, optional further formulation limits, and a vaccine adjuvant composition combined with an antigen.
Room-temperature stability of Formula I in citrate or succinate buffer substantially free of saline
A composition comprising the compound of Formula I, or pharmaceutically acceptable salts thereof, and a citrate or succinate buffer, or mixture thereof, from about 10 mM to about 50 mM, wherein the composition is substantially free of saline and stable when exposed to room temperature for 60 or more days.
Room-temperature stability of Formula I in citrate buffer substantially free of saline
A composition comprising the compound of Formula I, or pharmaceutically acceptable salts thereof, and a citrate buffer from about 10 mM to about 50 mM, wherein the composition is substantially free of saline and stable when exposed to room temperature for 60 or more days.
Buffered, low-saline citrate formulation with defined pH for Formula I
A composition comprising the compound of Formula I, or pharmaceutically acceptable salts thereof, and a citrate buffer from 15 mM to about 50 mM, wherein the composition is substantially free of saline and has a pH from about 4.5 to about 6.5.
Vaccine composition using a Formula I adjuvant in citrate or succinate buffer
A vaccine composition comprising an adjuvant formulation and an effective amount of an antigen, wherein the adjuvant formulation comprises an effective amount of the compound of Formula I, or pharmaceutically acceptable salts thereof, and a citrate or succinate buffer, or mixtures thereof, from 15 mM to about 50 mM.
Overall, the claims require Formula I formulated with citrate or succinate buffer in defined concentration ranges under substantially free of saline conditions, with room-temperature stability requirements. The claims also support optional aqueous buffered suspension attributes, phosphatidylcholine inclusion, and a vaccine embodiment using an effective antigen amount such as FimCH.
Stated Advantages
Stable when exposed to room temperature for 60 or more days, and at least 6 months in related embodiments.
Substantially reduced severe injection-site/systemic reactions versus prior adjuvants.
Documented Applications
UTI treatment or prevention using a vaccine approach where an antigen such as FimCH, or truncated FimH, is used to induce anti-FimH antibodies.
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