Vaccine formulations
View Patent ↗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.
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.