Rotavirus vaccine formulations
AssigneeMerck & Co., Inc.
InventorsCarl J. Burke, David B. Volkin
Life of this patent
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Abstract
The present invention provides liquid and lyophilized formulations of vaccines against rotavirus infection and methods of their preparation. The formulations include buffering agents appropriate for oral administration of rotavirus vaccines. The formulations also include compounds to stabilize of the vaccine compositions against loss of potency.
Claims17
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 of
- e) about 0.5% to about 1.25% of recombinant human serum albumin, and
- f) about 0.001% to about 2% non ionic surfactant.
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.
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.
Dependencies are inferred from the claim text.