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Last Updated: April 25, 2024

Claims for Patent: 8,084,039

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Summary for Patent: 8,084,039

Title:	Methods and compositions for live attenuated viruses
Abstract:	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.
Inventor(s):	Stinchcomb; Dan T. (Fort Collins, CO), Osorio; Jorge E. (Mount Horeb, WI), Wiggan; O\'Neil (Fort Collins, CO)
Assignee:	Inviragen, Inc. (Fort Collins, CO)
Application Number:	12/098,077
Patent Claims:	1. A live attenuated virus composition comprising: one or more live, attenuated viruses; one or more poly(ethylene oxide) and poly(propylene oxide) (EO-PO) block copolymers, the one or more EO-PO block copolymers include poloxamer 407, one or more proteins agents, the one or more protein agents include one or more albumins selected from the group consisting of lactalbumins and serum albumins, and one or more carbohydrate agents, the one or more carbohydrate agents include trehalose, wherein the composition is capable of reducing the inactivation of the live attenuated virus. 2. The virus composition of claim 1, wherein the live, attenuated viruses are selected from the group consisting of Flavivirus, Togavirus, Coronavirus, Rhabdovirus, Filovirus, Paramyxovirus, Orthomyxovirus, Bunyavirus, Arenavirus, Retrovirus, Hepadnavirus, Herpesvirus, Poxvirus families and combinations thereof. 3. The virus composition of claim 1, wherein the live, attenuated viruses are Flaviviruses. 4. The virus composition of claim 1, wherein the composition is in aqueous form. 5. The virus composition of claim 1, wherein the composition is partially or wholly dehydrated. 6. The virus composition of claim 1, wherein the one or more albumins include serum albumins derived from a vertebrate species. 7. The virus composition of claim 1, wherein the one or more co-polymers is poloxamer 407, the one or more protein agents is serum albumin, and the one or more carbohydrate agent is trehalose. 8. The virus composition of claim 7, wherein the one or more copolymers concentration is 0.1 to 4% (w/v), wherein the one or more albumins concentration is from 0.001 to 3% (w/v) and the one or more carbohydrates concentration is from 5 to 50% (w/v). 9. A method for decreasing inactivation of a live, attenuated virus composition comprising, combining one or more live attenuated viruses with a composition comprising one or more EO-PO block copolymers, the EO-PO block copolymers include poloxamer 407, one or more proteins agents, the one or more protein agents include one or more albumins selected from the group consisting of lactalbumins and serum albumins; and one or more carbohydrate agents, the one or more carbohydrate agents include trehalose, wherein the composition is capable of reducing inactivation of the live, attenuated virus. 10. The method of claim 9, wherein the live, attenuated viruses are selected from the group consisting of Flavivirus, Togavirus, Coronavirus, Rhabdovirus, Filovirus, Paramyxovirus, Orthomyxovirus, Bunyavirus, Arenavirus, Retrovirus, Hepadnavirus, Herpesvirus, Poxvirus families and combinations thereof. 11. The method of claim 9, further comprising partially or wholly dehydrating the combination. 12. The method of claim 11, further comprising partially or wholly re-hydrating the composition prior to administration. 13. The method of claim 9, wherein the composition increases the shelf life of an aqueous virus composition. 14. The method of claim 9, wherein the composition decreases inactivation of an aqueous live, attenuated virus for 24 hours or greater. 15. The method of claim 9, wherein the composition decreases inactivation of an aqueous live, attenuated virus during one or more freeze and thaw cycles. 16. The method of claim 9, wherein the one or more co-polymers is poloxamer 407, the one or more protein agents is serum albumin, and the one or more carbohydrate agent is trehalose. 17. The method of claim 9, wherein the virus composition is administered to a subject to reduce the onset of or prevent a health condition. 18. The method of claim 17, wherein the virus is selected from the group consisting of West Nile, Dengue, Japanese encephalitis, St. Louis encephalitis, Tick-borne encephalitis, and Yellow fever. 19. A kit for decreasing the inactivation of a live, attenuated virus composition comprising: at least one container; and a composition comprising one or more albumins, the one or more albumins selected from the group consisting of lactalbumins and serum albumins, one or more carbohydrate agents, the one or more carbohydrate agents include trehalose, and one or more EO-PO block copolymers, the EO-PO block copolymers include poloxamer 407. 20. The kit of claim 19, wherein at least one albumin is serum albumin. 21. The kit of claim 19, wherein the trehalose concentration is from 5 to 50% (w/v). 22. The kit of claim 19, wherein the poloxamer 407 concentration is from 0.1 to 4% (w/v). 23. The kit of claim 20, wherein the serum albumin concentration is from 0.001 to 3% (w/v). 24. The kit of claim 19, wherein the composition further comprises one or more live, attenuated viruses. 25. The kit of claim 24, wherein the live, attenuated viruses are selected from the group consisting of Flavivirus, Togavirus, Coronavirus, Rhabdovirus, Filovirus, Paramyxovirus, Orthomyxovirus, Bunyavirus, Arenavirus, Retrovirus, Hepadnavirus, Herpesvirus, Poxvirus families and combinations thereof. 26. A live attenuated virus composition comprising: one or more live, attenuated viruses; one or more EO-PO block co-polymers including poloxamer 407; having a concentration of 0.1 to 4% (w/v); one or more albumins, the one or more albumins selected from the group consisting of lactalbumins and serum albumins; having a concentration from 0.001 to 3% (w/v) and one or more carbohydrate agents, the one or more carbohydrate agent include trehalose, wherein the composition is capable of reducing the inactivation of the live attenuated virus and wherein the composition is in aqueous form. 27. The composition of claim 26, wherein the one or more albumins are serum albumins selected from the group consisting of, bovine serum albumin, canine serum albumin human serum albumin, and other serum albumins. 28. The composition of claim 27, wherein stabilization effects of the agents together are synergistic compared to individual agents. 29. The compositions of claim 27, wherein the composition is a more effective cryoprotectant than its individual agents. 30. The composition of claim 26, wherein the composition is in aqueous form and the composition increases shelf life of the live attenuated virus composition.

Details for Patent 8,084,039

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942	⤷ Try a Trial	2027-04-06
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954	⤷ Try a Trial	2027-04-06
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976	⤷ Try a Trial	2027-04-06
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978	⤷ Try a Trial	2027-04-06
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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