Claims
- 1. A liquid rotavirus vaccine formulation comprising:a) at least one strain of rotavirus about 1×105 to about 1000×105 pfu/mL; b) Sugar about 1 to about 70% (w/v); c) Phosphate about 0.01 to about 2 M; d) at least one Carboxylate about 0.05 to about 2 M; and, at least one component selected from the group consisting ofe) about 0.5% to about 1.25% of recombinant human serum albumin, and f) about 0.001% to about 2% non ionic surfactant.
- 2. The formulation of claim 1 wherein said at least one carboxylate is selected from the group consisting of succinate, citrate, fumarate, tartarate, maleate and lactate.
- 3. The formulation according to claim 1 wherein said sugar is selected from the group consisting of sucrose, mannitol, lactose, sorbitol, dextrose, fucose, trehalose, polyaspartic acid, inositol hexaphosphate (phytic acid), sialic acid or N-acetyineuraminic acid-lactose.
- 4. The liquid vaccine formulation of claim 1 further comprising: g)at least one diluent selected from the group consisting of Tissueculture medium, saline and water to volume.
- 5. The formulation of claim 1 wherein the concentration of sugar is between about to about 70%; the concentration of phosphate is between about 0.05 to about 0.3 M; and said at least one carboxylic acid is citrate or succinate at a concentration between about 0.05 to about 0.7 M.
- 6. The formulation according to claim 1 wherein the pH is between about pH 5.0 to about pH 8.0.
- 7. The formulation according to claim 1 wherein said phosphate is selected from the group consisting of monophosphates, polyphosphates and phosphorylated compounds.
- 8. The formulation according to claim 7 wherein said phosphorylated compounds are phosphorylated sugars.
- 9. The formulation according to claim 1 wherein the non ionic surfactant is selected from the group consisting of polysorbates, polyoxyethylene alkyl ethers, nonaethylene glycol octylphenol ethers, hepatethylene glycol octylphenyl ethers, sorbitan trioleates, and polyoxyethylene-polyoxypropylene block copolymers.
- 10. The formulation according to claim 1 wherein the concentration of surfactant is from about 0.005% to about 0.1%.
- 11. The rotavirus vaccine formulation of claim 1 wherein the non ionic surfactant is a polysorbate.
- 12. The rotavirus vaccine formulation of claim 11 wherein the non ionic surfactant is polysorbate 80.
- 13. A method of preparing rotavirus vaccine formulations, comprising:(a) cultivating a rotavirus and mixing the rotavirus with a concentrated stabilizing solution to form a virus bulk; and, optionally, (b) dialyzing the virus bulk to form a rotavirus vaccine solution; wherein the vaccine solution includes at least one component selected from the group consisting of (i) about 0.5% to about 1.25% of recombinant human serum albumin and (ii) about 0.1% to about 1.25% of at least one amino acid selected from the group amino acids consisting of glutamate, glutamine and arginine.
- 14. The method of claim 13 further comprising the step of lyophilizing the vaccine solution.
- 15. A method of administering an oral rotavirus vaccine formulation to an individual comprising treatment of the individual with a compound having sufficient buffering capacity to neutralize stomach acid, wherein the treatment is before, coincident with or subsequent to the administration of the vaccine;wherein the vaccine formulation includes at least one component selected from the group consisting of (i) about 0.5% toabout 1.25% of recombinant human serum albumin, (ii) about 0.001% to about 2% non ionic surfactant and (iii) about 0.1% to about 1.25% of at least one amino acid selected from the group amino acids consisting of glutamate, glutamine and arginine.
- 16. The method of claim 15 wherein the non ionic surfactant is a polysorbate.
- 17. The method of claim 16 wherein the non ionic surfactant is polysorbate 80.
CROSS-REFERENCE TO RELATED APPLICATIONS
This is a continuation-in-part of U.S. Ser. No. 09/366,616, filed Aug. 3, 1999 now U.S. Pat. No. 6,403,098, which is a continuation-in-part of U.S. Ser. No. 08/938,260, filed Sep. 26, 1997, now U.S. Pat. No. 5,932,223, which claims of benefits of U.S. Ser. No. 60/046,760, filed May 16, 1997 and U.S. Ser. No. 60/026,754, filed Sep. 26, 1996.
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May 1997 |
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Provisional Applications (2)
|
Number |
Date |
Country |
|
60/046760 |
May 1997 |
US |
|
60/026754 |
Sep 1996 |
US |
Continuation in Parts (2)
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Number |
Date |
Country |
Parent |
09/366616 |
Aug 1999 |
US |
Child |
09/631807 |
|
US |
Parent |
08/938260 |
Sep 1997 |
US |
Child |
09/366616 |
|
US |