Methods and compositions for live attenuated viruses
Embodiments herein relate to compositions of and methods for live viruses. In certain embodiments, a live, attenuated virus composition includes, but is not limited to, one or more live, attenuated viruses and compositions to reduce inactivation and/or degradation of the live, attenuated virus. In other embodiments, the live, attenuated virus composition may be a vaccine composition. In yet other compositions, a live, attenuated virus composition may include at least one carbohydrate, at least one protein and at least one high molecular weight surfactants for reducing inactivation and/or degradation of the live, attenuated virus.
1. A virus composition comprising:
one or more live, attenuated flaviviruses; and a stabilizing composition comprising serum albumin and trehalose,
wherein the one or more live, attenuated flaviviruses consist of one or more Dengue viruses;
wherein the serum albumin is serum albumin from a vertebrate species, and is present at a concentration of 0.001% to 3.0% (w/v);
wherein the trehalose is present at a concentration of at least 5% (w/v); and
wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses.
2. The virus composition according to claim 1 , wherein the trehalose is present at a concentration of a 5% to 50% (w/v).
3. The virus composition according to claim 1 , wherein the trehalose is present at a concentration of at least 10% (w/v).
4. The virus composition according to claim 1 , wherein the trehalose is present at a concentration of 5% to 15% (w/v).
5. The virus composition according to claim 4 , wherein the trehalose is present at a concentration of 10% to 15% (w/v).
6. The virus composition of claim 1 , wherein the serum albumin from a vertebrate species is from a human, a canine, or a bovine source.
7. The virus composition of claim 6 , wherein the serum albumin from a vertebrate species is from a human source.
8. The virus composition of claim 1 , wherein the serum albumin is recombinant albumin.
9. The virus composition of claim 1 , wherein the virus composition further comprises one or more poly(ethylene oxide) and poly(propylene oxide) (EO-PO) block copolymers, and the one or more EO-PO block copolymers include poloxamer 407.
10. A method for decreasing inactivation of one or more live, attenuated Dengue viruses comprising:
combining one or more live, attenuated Dengue viruses with a stabilizing composition comprising serum albumin and trehalose,
wherein the serum albumin is serum albumin from a vertebrate species, and is present at a concentration of 0.001% to 3.0% (w/v);
wherein the trehalose is present at a concentration of at least 5% (w/v), and
wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses.
11. The method according to claim 10 , wherein the trehalose is present at a concentration of a 5% to 50% (w/v).
12. The method according to claim 10 , wherein the trehalose is present at a concentration of at least 10% (w/v).
13. The method according to claim 10 , wherein the trehalose is present at a concentration of 5% to 15% (w/v).
14. The method according to claim 13 , wherein the trehalose is present at a concentration of 10% to 15% (w/v).
15. The method of claim 10 , further comprising partially or wholly dehydrating the combination.
16. The method of claim 10 , further comprising partially or wholly re-hydrating the composition prior to administration.
17. The method of any one of claim 10 , wherein the composition increases the shelf life of an aqueous Dengue virus composition.
18. The method of claim 10 , wherein the composition decreases inactivation of an aqueous live, attenuated Dengue virus for 24 hours or greater.
19. The method of claim 10 , wherein the composition decreases inactivation of an aqueous live, attenuated Dengue virus during one or more freeze and thaw cycles.
20. The method of claim 10 , wherein the composition comprises one or more live, attenuated Dengue viruses and is administered to a subject to reduce the onset of a health condition caused by the Dengue viruses.
21. A kit for decreasing the inactivation of Dengue viruses comprising:
at least one container; and
a composition comprising one or more live, attenuated Dengue viruses; and a stabilizing composition comprising: serum albumin and trehalose,
wherein the serum albumin is serum albumin from a vertebrate species, and is present at a concentration of 0.001% to 3.0% (w/v);
wherein the trehalose is present at a concentration of at least 5% (w/v); and
wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses.
22. The kit according to claim 21 , wherein the trehalose is present at a concentration of a 5% to 50% (w/v).
23. The kit according to claim 21 , wherein the trehalose is present at a concentration of at least 10% (w/v).
24. The kit according to claim 21 , wherein the trehalose is present at a concentration of 5% to 15% (w/v).
25. The kit according to claim 21 , wherein the trehalose is present at a concentration of 10% to 15% (w/v).
26. The kit of claim 21 , wherein the serum albumin is human serum albumin.