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US 2022/0088176 A1Published application
Adjuvanted nanoparticulate influenza vaccine
OwnerPeter BLACKBURN, Stephen GRIMESinventors
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Abstract
Vaccine compositions comprising influenza antigens formulated as nanoparticulate water in oil miniemulsions. The vaccines may be formulated at the point of use and are useful in emergency response conditions.
Claims32
1-18. (canceled)
A kit for the point-of-use administration of a nanoparticulate water-in-oil emulsion vaccine against an infectious agent comprising:
- a vial of an adjuvant oil comprising mannide monooleate, squalene and squalane, a vial of aqueous PBS for combining with an antigen, at least one syringe, a lipid resistant three-way stopcock, at least one needle, and a vial for storing the formulated water-in-oil emulsion vaccine.
A method for a point of use formulation of an adjuvanted nanoparticulate water-in-oil emulsion vaccine comprising:
- preparing an aqueous solution of a proteinaceous antigen, transferring a suitable amount of the aqueous solution to a sterile container containing a predetermined amount of an adjuvant oil comprising mannide monooleate, squalene and squalane, shaking the container so as to mix the contents to form a milky pre-emulsion, transferring an aliquot of the milky pre-emulsion to a first sterile syringe, connecting the first sterile syringe to a sterile three-way stopcock, attaching a second sterile syringe to the three-way stopcock at a 90 degree angle to the first syringe, passing the emulsion from one syringe to the other by manually depressing the plunger of each respective syringe in a serial fashion for a sufficient number of cycles so as to create an emulsion of the aqueous solution in the adjuvant oil wherein the median globule size is from about 0.3 μm to about 1 μm.
A method of producing an influenza vaccine composition comprising:
- (i) preparing an aqueous phase comprising proteinaceous antigens for each of a plurality of influenza vaccine strains;
- (ii) preparing a water-in-oil emulsion of the aqueous phase with an oil phase wherein:
- the aqueous phase of the emulsion comprises from about 25% to about 35% by weight of the vaccine composition;
- and
- the oil phase comprises from about 65% to about 75% by weight of the emulsion, and comprises from about 85% to about 95% by weight of squalene and squalane, and from about 9% to about 12% by weight of mannide monooleate and from about 0.5% to about 0.7% of polyoxyl-40-hydrogenated castor oil;
- and
- (iii) processing the emulsion to form a nanoparticulate water-in-oil emulsion comprising globules of the aqueous phase of a median diameter from about 0.3 μm to about 1 μm;
- wherein:
- (i) said vaccine has enhanced cross-reactivity to influenza antigens not contained in the vaccine as compared to an unadjuvanted vaccine consisting essentially of the proteinaceous antigens;
- (ii) said vaccine has increased response rate in elderly and immunocompromised subjects as compared to an unadjuvanted vaccine consisting essentially of the proteinaceous antigens;
- and
- (iii) said vaccine provides an extended period of protective antibody titers as compared to an unadjuvanted vaccine consisting essentially of the proteinaceous antigens.
9 more elements
A method of producing an influenza vaccine composition comprising:
- (i) preparing an aqueous phase comprising proteinaceous antigens for each of a plurality of influenza vaccine strains;
- (ii) preparing a water-in-oil emulsion of the aqueous phase with an oil phase wherein:
- the aqueous phase of the emulsion comprises from about 25% to about 35% by weight of the vaccine composition;
- and
- the oil phase comprises from about 65% to about 75% by weight of the emulsion, and comprises from about 85% to about 95% by weight of squalene and squalane, and from about 9% to about 12% by weight of mannide monooleate and from about 0.5% to about 0.7% of polyoxyl-40-hydrogenated castor oil;
- and
- (iii) processing the emulsion to form a nanoparticulate water-in-oil emulsion comprising globules of the aqueous phase of a median diameter from about 0.3 μm to about 1 μm;
- wherein said vaccine has enhanced immunopotency.
5 more elements
A method of producing an immune response to influenza, comprising administering to a patient a nanoparticle water-in-oil adjuvant influenza vaccine, said vaccine comprising:
- a nanoparticulate water-in-oil emulsion having a viscosity of 100 cP or less;
- an aqueous phase which comprises about 25% to about 35% by weight of the emulsion, which aqueous phase is in the form of globules of a median diameter from about 0.3 μm to about 1 and contains said one or more influenza antigens;
- and
- an oil phase which comprises from about 65% to about 75% by weight of the emulsion, which oil phase contains from about 85% to about 90% of squalene and squalane, from about 9% to about 12% of mannide monooleate, and from about 0.5% to about 0.7% of polyoxyl-40-hydrogenated castor oil, each by weight of the oil phase;
- wherein the nanoparticle water-in-oil adjuvant vaccine has:
- enhanced immunopotency to the influenza antigens compared to an unadjuvanted vaccine comprising the same or a higher concentration of the same influenza antigens;
- enhanced cross-reactivity to influenza antigens not contained in the vaccine;
- increased efficacy in elderly and immunocompromised subjects;
- and
- enhanced durability.
7 more elements
Dependencies are inferred from the claim text.