Stabilizers containing recombinant human serum albumin for live virus vaccines
AssigneeMerck & Co., Inc.
InventorsCarl Burke, David Volkin
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Abstract
Compositions are provided for improving the stability of live virus vaccines containing, e.g., live varicella zoster, measles, mumps, and rubella viruses. Such improved stabilizers are aqueous solutions containing recombinant human serum albumin (rHA) as a component at from 1-100 g/l. Live virus vaccines as well as methods of preparing live virus vaccines containing the stabilizers are also provided.
Claims19
A live virus vaccine comprising:
- (a) live varicella zoster;
- and
- (b) recombinant human serum albumin (rHA) at a concentration of 0.1% to 10% (w/v) wherein the rHA has been made in yeast.
A live virus vaccine comprising:
- (a) live varicella zoster;
- and
- (b) Medium 199 containing:
- rHA at a concentration of 0.1% to 10%;
- 50 μg/ml neomycin;
- 2 mM L-glutamine and;
- 25% SPG
- where SPG contains, on a per liter basis:
- Sucrose 74.62 g KH2PO4 0.52 g K2HPO4 1.25 g Potassium L-glutamate 0.912 g
- wherein the rHA has been made in yeast.
A method of preparing a live virus vaccine that comprises mixing live varicella zoster with a stabilizer comprising an aqueous solution of recombinant human serum albumin (rHA) at 1-100 g/l;
- a sugar or sugar alcohol at 20-90 g/l;
- a mono- or dibasic alkali metal phosphate salt or mixture thereof at a total phosphate concentration of from 0.5 to 3 g/l;
- a glutamic acid alkali metal salt at 0.5 to 2 g/l;
- and a combination of sodium and potassium chloride providing a total chloride concentration of 4-10 g/l wherein the rHA has been made in yeast.
A method of harvesting varicella zoster virus for use in a live virus vaccine that includes the step of disrupting cells containing varicella zoster virus in the presence of a stabilizer comprising an aqueous solution of recombinant human serum albumin (rHA) at 1-100 g/l;
- a sugar or sugar alcohol at 20-90 g/l;
- a mono- or dibasic alkali metal phosphate salt or mixture thereof at a total phosphate concentration of from 0.5 to 3 g/l;
- a glutamic acid alkali metal salt at 0.5 to 2 g/l;
- and a combination of sodium and potassium chloride providing a total chloride concentration of 4-10 g/l wherein the rHA has been made in yeast.
Dependencies are inferred from the claim text.