Dengue vaccine formulation
AssigneeTakeda Vaccines, Inc.
InventorsSushma Kommareddy, Sara Yazdi
Life of this patent
Estimating the term…
Abstract
The present invention relates to a dengue vaccine formulation comprising a tetravalent dengue virus composition comprising a live attenuated dengue virus serotype 1, a live attenuated dengue virus serotype 2, a live attenuated dengue virus serotype 3, and a live attenuated dengue virus serotype 4, at least one non-reducing disaccharide, at least one poloxamer, urea, at least one amino acid having a positively charged side chain at neutral pH, tromethamine, and human serum albumin.
Claims33
A dengue vaccine formulation comprising:
- A. a tetravalent dengue virus composition comprising:
- (i) a live attenuated dengue virus serotype 1,
- (ii) a live attenuated dengue virus serotype 2,
- (iii) a live attenuated dengue virus serotype 3, and
- (iv) a live attenuated dengue virus serotype 4;
- and
- B. an excipient composition comprising:
- a. trehalose,
- b. poloxamer,
- c. urea,
- d. arginine hydrochloride,
- e. tromethamine, and
- f. human serum albumin.
A method of preparing a dengue vaccine formulation in dry form comprising the following steps:
- (a) providing a dengue vaccine formulation in aqueous form,
- (b) freezing the dengue vaccine formulation in aqueous form to form a frozen dengue vaccine formulation,
- (c) subjecting the frozen dengue vaccine formulation to a primary drying step in an apparatus with a shelf temperature, which ranges from above the glass transition temperature Tg of the formulation to not more than 25° C., for example not more than 15° C., above the glass transition temperature Tg and at a pressure below 0.1 mbar to form a primary dried product, and
- (d) subjecting the primary dried product to a secondary drying step in an apparatus with a shelf temperature, which is above the shelf temperature of the primary drying step and at a pressure below 1 mbar to form a secondary dried product.
Dependencies are inferred from the claim text.