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US 10,946,087 B2Granted
Vaccine compositions against dengue virus diseases
AssigneeSanofi Pasteur Limited
InventorsNadia Tornieporth, Alain Bouckenooghe, Fernando Noriega, Melanie Saville, Nicholas Jackson, Yves Girerd-Chambaz
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Abstract
The present invention relates to vaccine compositions that are useful in a method of protecting a human subject against dengue disease.
Claims27
A method of protecting a dengue immune human subject against dengue disease caused by a dengue virus of serotype 2, comprising
- A) administering only 2 doses of an effective amount of a vaccine composition to the dengue immune human subject, wherein the doses are 6 months apart, and wherein said composition comprises:
- a dengue antigen of each of serotypes 1 to 4, wherein said dengue antigens of serotypes 1 to 4 are each a live attenuated chimeric dengue virus comprising a yellow fever virus genome whose prM-E sequence has been substituted with the prM-E sequence of a dengue virus;
- wherein the prM-E sequence of the dengue antigen of serotype 1 comprises SEQ ID NO:
- 1, the prM-E sequence of the dengue antigen of serotype 2 comprises SEQ ID NO:
- 2, the prM-E sequence of the dengue antigen of serotype 3 comprises SEQ ID NO:
- 3 and the prM-E sequence of the dengue antigen of serotype 4 comprises SEQ ID NO:
- 4:
- wherein each dose of tetravalent vaccine comprises 5±1 log10 CCID50 of each live attenuated chimeric dengue virus;
- wherein the route of administration is subcutaneous;
- and
- wherein said dengue immune human subject is aged between 2 and 60 years old;
- and
- B) protecting the dengue immune human subject against dengue disease caused by a dengue virus of serotype 2.
10 more elements
A method of protecting a dengue immune human subject against dengue disease caused by a dengue virus of serotype 2, comprising
- A) administering only 2 doses of an effective amount of a vaccine composition to the dengue immune human subject, wherein the doses are 6 months apart, and wherein said composition comprises:
- a dengue antigen of each of serotypes 1 to 4, wherein said dengue antigens of serotypes 1 to 4 are each a live attenuated chimeric dengue virus comprising a yellow fever virus genome whose prM-E sequence has been substituted with the prM-E sequence of a dengue virus;
- wherein the prM-E sequence of the dengue antigen of serotype 1 comprises SEQ ID NO:
- 1, the prM-E sequence of the dengue antigen of serotype 2 comprises SEQ ID NO:
- 2, the prM-E sequence of the dengue antigen of serotype 3 comprises SEQ ID NO:
- 3 and the prM-E sequence of the dengue antigen of serotype 4 comprises SEQ ID NO:
- 4;
- wherein each dose of tetravalent vaccine comprises 5±1 log10 CCID50 of each live attenuated chimeric dengue virus;
- wherein the route of administration is subcutaneous;
- wherein the vaccine composition further comprises a pharmaceutically acceptable carrier which is 0.4% NaCl buffer containing excipients consisting of essential amino acids, non-essential amino acids, L-arginine chlorhydrate, saccharose, D-trehalose, dehydrate, sorbitol, tris (hydroxymethyl) aminoethane and urea;
- wherein the vaccine composition is administered in a volume between 0.1 and 1.0 ml;
- wherein said subject is aged between 2 and 60 years old;
- wherein the dengue immune human subject is in good health based on medical history and physical examination;
- and
- wherein said subject resides in a dengue endemic area;
- and
- B) protecting the dengue immune human subject against dengue disease caused by a dengue virus of serotype 2.
14 more elements
Dependencies are inferred from the claim text.