Microfluidized oil-in-water emulsions and vaccine compositions
First Claim
Patent Images
1. A submicron oil-in-water emulsion useful as a vaccine adjuvant comprising a light hydrocarbon non-metabolizable oil, a surfactant, and an aqueous component, wherein said oil is dispersed in said aqueous component and the mean oil droplet size is less than 1 μ
- m.
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Abstract
This invention provides submicron oil-in-water emulsions useful as a vaccine adjuvant for enhancing the immunogenicity of antigens. The present invention also provides vaccine compositions containing an antigen combined with such emulsions intrinsically or extrinsically. Methods of preparing the emulsions and vaccines are also provided by the present invention.
193 Citations
66 Claims
- 1. A submicron oil-in-water emulsion useful as a vaccine adjuvant comprising a light hydrocarbon non-metabolizable oil, a surfactant, and an aqueous component, wherein said oil is dispersed in said aqueous component and the mean oil droplet size is less than 1 μ
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10. A submicron oil-in-water emulsion useful as a vaccine adjuvant comprising about 40% v/v of mineral oil, about 10% w/v of lecithin, about 0.18% v/v of TWEEN®
- -80, about 0.08% v/v of SPAN®
-80, and an aqueous phase, wherein said oil is dispersed in said aqueous phase and the mean oil droplet size is between 0.1 μ
m to 0.5 μ
m.
- -80, about 0.08% v/v of SPAN®
-
12. A method of preparing a submicron oil-in-water emulsion, comprising:
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(a) preparing a mixture by combining a light hydrocarbon non-metabolizable oil, a surfactant, and an aqueous component;
(b) subjecting said mixture to a primary emulsification process to produce an oil-in-water emulsion which has a mean oil droplet size of 1.0 μ
m to 1.1 μ
m ; and
(c) subjecting the oil-in-water emulsion prepared in (b) to microfluidization to produce said submicron oil-in-water emulsion, wherein the submicron emulsion has a mean oil droplet size of less than 1 μ
m. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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- 24. A vaccine composition comprising an oil-in-water emulsion and an antigen, wherein said antigen is dispersed in said emulsion, said emulsion comprises a light hydrocarbon non-metabolizable oil, a surfactant and an aqueous component, and wherein the mean oil droplet size of said emulsion is less than 1 μ
-
28. The vaccine composition of 24 wherein said light hydrocarbon non-metabolizable oil is light mineral oil.
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38. A method of preparing a vaccine composition, comprising:
-
(a) preparing a mixture by combining a light hydrocarbon non-metabolizable oil, a surfactant, and an aqueous component;
(b) combining an antigen with the mixture formed in (a);
(c) subjecting the mixture containing said antigen, which is formed in (b), to a primary emulsification process to produce an oil-in-water emulsion which has a mean oil droplet size of 1.0 μ
m to 1.1 μ
m; and
(d) subjecting the emulsion formed in (c) to high pressrure homogenization to produce said vaccine composition, wherein the composition has a mean oil droplet size of less than 1 μ
m. - View Dependent Claims (39, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
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40. A method of preparing a vaccine composition, comprising:
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(a) combining an antigen with a saponin to form a mixture;
(b) subjecting the mixture formed in (a) to homogenization;
(c) adding a sterol to the homogenized mixture formed in (b);
(d) subjecting the mixture formed in (c) to homogenization;
(e) preparing a mixture of a light hydrocarbon non-metabolizable oil, a surfactant, and an aqueous component;
(f) adding the mixture of (e) to the homogenized mixture formed in (d);
(g) subjecting the mixture formed in (f) to further homogenization to produce an oil-in-water emulsion which has a mean oil droplet size of 1.0 μ
m to 1.1 μ
m; and
(h) subjecting the emulsion formed in (c) to high pressure homogenization to produce said vaccine composition, wherein the composition has a mean oil droplet size of less than 1 μ
m.
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- 56. A vaccine composition comprising an microencapsulated antigen and an oil-in-water emulsion, wherein said microencapsulated antigen is dispersed in said emulsion, and said emulsion comprises a light hydrocarbon non-metabolizable oil, a surfactant and an aqueous component, and wherein the mean oil droplet size of said emulsion is less than 1 μ
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60. The vaccine composition of 56 wherein said light hydrocarbon non-metabolizable oil is light mineral oil.
Specification