IP Library Granted Patent US 10,525,120
Granted Patent B2
US 10,525,120 · App. 15/194,297 · Granted Jan 7, 2020

Methods and compositions for live attenuated viruses

Inventors: Dan Stinchcomb (Fort Collins, CO); Jorge E. Osorio (Mount Horeb, WI); O'Neil Wiggan (Fort Collins, CA)
Assignee: TAKEDA VACCINES, INC.
A61K39/12A61K47/26A61K47/36A61K47/42C08L71/02C12N7/00A61K2039/5254A61K2039/55555A61K2039/70C08G2650/58C08L2203/02C12N2710/10051C12N2710/10061C12N2710/24151C12N2710/24161C12N2760/16051C12N2760/16061C12N2760/18411C12N2770/24134C12N2770/24151C12N2770/24161C12N2770/36151C12N2770/36161Y02A50/386Y02A50/388Y02A50/39Y02A50/394Y02A50/396
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Quick Facts
Patent No.
US 10,525,120
App. No.
15/194,297
Granted
Jan 7, 2020
Kind
B2
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.

Claims (27)

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 consists 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 15% (w/v); and

wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses.

2. 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 15% (w/v); and

wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses.

3. The method of claim 2 , further comprising partially or wholly dehydrating the combination.

4. The method of claim 3 , further comprising partially or wholly re-hydrating the combination prior to administration.

5. The method of claim 2 , wherein the composition increases the shelf life of an aqueous Dengue virus composition.

6. The method of claim 2 , wherein the composition decreases inactivation of an aqueous live, attenuated Dengue virus for 24 hours or greater.

7. The method of claim 2 , wherein the composition decreases inactivation of an aqueous live, attenuated Dengue virus during one or more freeze and thaw cycles.

8. The method of claim 2 , 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.

9. A kit for decreasing 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 15% (w/v); and

wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses.

10. The kit of claim 9 , wherein the serum albumin is human serum albumin.

11. The virus composition of claim 1 , wherein the serum albumin is recombinant serum albumin.

12. The virus composition of claim 1 , wherein the serum albumin from a vertebrate species is from a human, a canine, or a bovine source.

13. 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.

14. The virus composition of claim 12 , wherein the serum albumin from a vertebrate species is from a human source.

Assignments (3)
CHANGE OF ASSIGNEE ADDRESS RECORDED ON REEL 044033, FRAME 0353 Recorded Aug 29, 2019
From: TAKEDA VACCINES, INC.
To: TAKEDA VACCINES, INC.
Reel/Frame 050234/0735 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 3, 2017
From: STINCHCOMB, DAN T.; OSORIO, JORGE E.; WIGGAN, O'NEIL
To: INVIRAGEN, INC.
Reel/Frame 044033/0335 →
MERGER AND CHANGE OF NAME Recorded Nov 3, 2017
From: INVIRAGEN, INC.; TAKEDA VACCINES (MONTANA), INC.
To: TAKEDA VACCINES, INC.
Reel/Frame 044033/0353 →
Continuity (4)
Division 13300217 · Nov 18, 2011
Division 12098077 · Apr 4, 2008
Provisional Application 60910579 · Apr 6, 2007
Related Publication 20170100474A1 · Apr 13, 2017