초록 ▼

The present invention provides for a novel oil-in-water (O/W) emulsion, with increased stability in the presence of bacterial or viral suspensions, especially those concentrated and non-purified or weakly purified. The emulsion of the present invention can act as vehicle for the delivery of a pharm

The present invention provides for a novel oil-in-water (O/W) emulsion, with increased stability in the presence of bacterial or viral suspensions, especially those concentrated and non-purified or weakly purified. The emulsion of the present invention can act as vehicle for the delivery of a pharmaceutical composition comprising at least one immunogen and, in particular, an immunogen selected from the group comprising an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof.

대표청구항 ▼

What is claimed is: 1. A vaccine composition comprising an injectable oil-in-water (O/W) emulsion, comprising: (i) an aqueous solution containing at least one immunogen; (ii) a mineral oil; (iii) a non-ionic lipophilic surfactant; (iv) a non-ionic hydrophilic surfactant having a high hydrophilic-li

What is claimed is: 1. A vaccine composition comprising an injectable oil-in-water (O/W) emulsion, comprising: (i) an aqueous solution containing at least one immunogen; (ii) a mineral oil; (iii) a non-ionic lipophilic surfactant; (iv) a non-ionic hydrophilic surfactant having a high hydrophilic-lipophilic balance (HLB) value of greater than 13 and less than 40; and (v) a non-ionic hydrophilic surfactant having a low hydrophilic-lipophilic balance (HLB) value between 9 and 13. 2. A vaccine composition comprising an injectable oil-in-water (O/W) emulsion, comprising: (i) an aqueous solution containing at least one immunogen, (ii) a paraffin oil, (iii) a sorbitan monooleate, (iv) an ethoxylated sorbitan monooleate and (v) an ethoxylated sorbitan trioleate. 3. The composition of claim 2, wherein the paraffin oil is present at a concentration of 29.3% v/v, the sorbitan monooleate is present at a concentration of 0.6% w/v, the ethoxylated sorbitan trioleate is present at a concentration of 3.4% w/v and the ethoxylated sorbitan monooleate is present at a concentration of 0.75% w/v. 4. The composition of claim 1, wherein the immunogen is selected from the group consisting of an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof. 5. The composition of claim 4, wherein the immunogen is an inactivated porcine circovirus type 2 (PCV-2) virus. 6. A method for inducing an immunological response in an animal against a pathogen comprising administering to said animal a vaccine composition according to claim 4. 7. A method according to claim 6, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 8. A vaccine composition comprising an injectable oil-in-water (O/W) emulsion, comprising: (i) an aqueous solution containing at least one immunogen; (ii) a mineral oil; (iii) a non-ionic lipophilic surfactant; and (iv) a non-ionic hydrophilic surfactant having a low hydrophilic-lipophilic balance (HLB) value between 11 and 13, said non-ionic hydrophilic surfactant is selected from the group consisting of ethoxylated fatty acid diesters of sorbitan. 9. A method for inducing an immunological response in an animal against a pathogen comprising administering to said animal a vaccine composition according to claim 1. 10. A method for inducing an immunological response in an animal against a pathogen comprising administering to said animal a vaccine composition according to claim 2. 11. A method for inducing an immunological response in an animal against a pathogen comprising administering to said animal a vaccine composition according to claim 8. 12. A method for inducing a gamma-interferon (IFNγ) response in an animal comprising administering to said animal a composition according to claim 1. 13. A method for inducing a gamma-interferon (IFNγ) response in an animal comprising administering to said animal a composition according to claim 2. 14. A method for inducing a gamma-interferon (IFNγ) response in an animal comprising administering to said animal a composition according to claim 4. 15. A method for inducing a gamma-interferon (IFNγ) response in an animal comprising administering to said animal a composition according to claim 8. 16. A method according to claim 9, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 17. A method according to claim 10, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 18. A method according to claim 11, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 19. A method according to claim 12, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 20. A method according to claim 13, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 21. A method according to claim 14, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 22. A method according to claim 15, wherein the animal is a pig, wherein the vaccine composition is administered in a single dose and wherein the administration is an intramuscular (IM) injection. 23. A kit having at least 2 vials, comprising: an immunogen in a first vial and an emulsion comprising an oily phase comprising a non-ionic lipophilic surfactant, a non-ionic hydrophilic surfactant having a low hydrophilic-lipophilic balance (HLB) value between 9 and 13, a mineral oil and an aqueous phase comprising a non-ionic hydrophilic surfactant having a high hydrophilic-lipophilic balance (HLB) value of greater than 13 and less than 40 in a second vial. 24. A kit having at least 2 vials, comprising: an immunogen in a first vial and an emulsion an oily phase comprising a sorbitan monooleate, an ethoxylated sorbitan trioleate, a paraffin oil and an aqueous phase comprising an ethoxylated sorbitan monooleate in a second vial. 25. A kit having at least 2 vials, comprising: an immunogen in a first vial and an emulsion comprising an oily phase comprising a sorbitan monooleate at a concentration of 1.8% w/v, an ethoxylated sorbitan trioleate at a concentration of 10.2% w/v, a paraffin oil at a concentration of 88% v/v and an aqueous phase comprising an ethoxylated sorbitan monooleate at a concentration of 2.25% w/v in a second vial. 26. The composition of claim 1, wherein the non-ionic lipophilic surfactant is present at a concentration 0.1% to 2.5% w/v. 27. The composition of claim 1, wherein the high HLB non-ionic hydrophilic surfactant is present at a concentration of 0.1% to 1.5% w/v. 28. The composition of claim 1, wherein the low HLB non-ionic hydrophilic surfactant is present at a concentration of 1% to 8% w/v. 29. The composition of claim 1, wherein the mineral oil is present at a concentration of 5% to 50% v/v.