Methods and compositions for nanoemulsion vaccine formulations
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Publication Number
US-11173197-B2
Publication Date
2021-11-16
Expiration Date
Abstract
The present disclosure relates to nanoemulsion vaccine compositions and methods of making and using the same. The disclosed compositions and methods provide a means of treating, preventing, or protecting an individual from anthrax exposure or poisoning.
Core Innovation
The disclosed invention relates to an aqueous anthrax recombinant protective antigen (rPA) composition formulated with a nanoemulsion and a defined stabilizing system. The stabilizing system consists of TRIS buffer, at least one salt, glycerol or at least one sugar selected from trehalose and sucrose, histidine, and optionally at least one antioxidant.
The problem addressed is that rPA in the presence of a nanoemulsion can undergo degradation over time, resulting in loss of potency compared to a composition comprising rPA and a nanoemulsion but lacking the stabilizing system. The stabilizing system is intended to protect rPA from degradation over time and preserve potency by maintaining rPA antigen content following storage.
Preserved potency is demonstrated by retaining at least about 80% rPA following storage at about 5° C. for at least 12 months as determined by RP-HPLC and/or SEC-HPLC. The disclosure also describes stability and potency retention associated with TRIS buffer, specific salts, histidine, and sugars such as trehalose and sucrose.
Claims Coverage
The provided claim content includes one independent claim describing an aqueous composition and its potency-preservation criterion. The independent claim requires a defined stabilizing system and a quantified rPA retention threshold.
Aqueous rpa nanoemulsion composition with defined stabilizing system
An aqueous composition consisting of recombinant protective antigen (rPA) of anthrax, a nanoemulsion, and a stabilizing system that consists of TRIS buffer, at least one salt, glycerol or at least one sugar selected from trehalose and sucrose, histidine, and optionally at least one antioxidant.
Potency preservation by protecting rpa from degradation
The composition preserves the potency of the rPA antigen by protecting it from degradation over time as compared to a composition comprising rPA and a nanoemulsion but lacking the stabilizing system.
Retention of at least about 80% rpa after storage
Preserved potency is demonstrated by the formulation retaining at least about 80% rPA following storage at about 5° C. for at least 12 months as determined by RP-HPLC and/or SEC-HPLC.
Coverage centers on an aqueous rPA and nanoemulsion composition that uses a defined TRIS-based stabilizing system to protect rPA from degradation and preserve potency, with potency preservation quantified by retention of at least about 80% rPA after extended storage using RP-HPLC and/or SEC-HPLC.
Stated Advantages
Preserves the potency of the rPA antigen by protecting it from degradation over time as compared to a composition comprising rPA and a nanoemulsion but lacking the stabilizing system.
Retains at least about 80% rPA following storage at about 5° C. for at least 12 months as determined by RP-HPLC and/or SEC-HPLC.
Documented Applications
A nanoemulsion vaccine formulation for anthrax using an aqueous composition containing anthrax recombinant protective antigen (rPA), a nanoemulsion, and the defined stabilizing system.
Intranasal administration.
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