US 12,186,363 B2
Compositions and methods for dengue virus chimeric constructions in vaccines
Dan T. Stinchcomb, Enumclaw, WA (US); Claire Kinney, Fort Collins, CO (US); Richard M. Kinney, Fort Collins, CO (US); and Jill A. Livengood, Fort Collins, CO (US)
Assigned to Takeda Vaccines, Inc., Cambridge, MA (US); and The Government of the United States of America as Represented by the Secretary of the Department of Health and Human Services, Atlanta, GA (US)
Filed by TAKEDA VACCINES, INC., Cambridge, MA (US); and THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY OF THE DEPARTMENT, Atlanta, GA (US)
Filed on Sep. 17, 2021, as Appl. No. 17/478,537.
Application 15/492,981 is a division of application No. 14/209,808, filed on Mar. 13, 2014, granted, now 9,783,579, issued on Sep. 20, 2017.
Application 17/478,537 is a continuation of application No. 16/561,755, filed on Sep. 5, 2019, abandoned.
Application 16/561,755 is a continuation of application No. 15/492,981, filed on Apr. 20, 2017, granted, now 10,449,231, issued on Oct. 2, 2019.
Claims priority of provisional application 61/800,204, filed on Mar. 15, 2013.
Prior Publication US 2022/0062375 A1, Mar. 3, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/12 (2006.01); A61K 31/7048 (2006.01); A61K 31/713 (2006.01); A61K 38/16 (2006.01); C07K 14/005 (2006.01); C07K 14/18 (2006.01); C07K 19/00 (2006.01); C12N 15/09 (2006.01); C12N 15/861 (2006.01); A61K 39/00 (2006.01); A61P 31/14 (2006.01)
CPC A61K 38/162 (2013.01) [A61K 31/7048 (2013.01); A61K 31/713 (2013.01); A61K 39/12 (2013.01); C07K 14/005 (2013.01); C07K 14/1825 (2013.01); C07K 19/00 (2013.01); C12N 15/09 (2013.01); C12N 15/8613 (2013.01); A61K 2039/5254 (2013.01); A61K 2039/70 (2013.01); A61P 31/14 (2018.01); C07K 2319/00 (2013.01); C12N 2770/24122 (2013.01); C12N 2770/24134 (2013.01); C12N 2770/24141 (2013.01); C12N 2770/24143 (2013.01); C12N 2770/24162 (2013.01); Y02A 50/30 (2018.01)] 30 Claims
 
1. An immunogenic composition comprising a modified live, attenuated dengue-2 virus strain PDK-53, the immunogenic composition being a tetravalent composition, wherein the modified live, attenuated dengue-2 virus strain PDK-53
is encoded by a polynucleotide molecule encoding a modified live, attenuated dengue-2 virus strain PDK-53 polypeptide molecule,
comprises an RNA transcribed from a cDNA comprising a polynucleotide molecule encoding the modified live, attenuated dengue-2 virus strain PDK-53 polypeptide molecule,
comprises one or more polypeptide molecules encoded by a polynucleotide molecule encoding the modified live, attenuated dengue-2 virus strain PDK-53 polypeptide molecule, or
is obtainable by a method for producing a modified live, attenuated dengue-2 virus strain PDK-53, the method comprising the following steps:
a) transcribing an RNA from a cDNA comprising a polynucleotide molecule encoding the modified live, attenuated dengue-2 virus strain PDK-53 polypeptide molecule, and
b) introducing the RNA transcribed in step a) into cells for production of the modified live, attenuated dengue-2 virus strain PDK-53,
wherein the polynucleotide molecule encoding the modified live, attenuated dengue-2 virus strain PDK-53 polypeptide molecule comprises at least one mutation, wherein one or more mutation is selected from the group consisting of:
an adenine to guanine mutation at position 592 in the numbering of SEQ ID NO: 14 encoding a glutamic acid instead of a lysine in the polypeptide molecule at amino acid position 166 in the numbering of SEQ ID NO: 6 corresponding to prM-52, and
an adenine to guanine mutation at position 8803 in the numbering of SEQ ID NO: 14 encoding a valine instead of an isoleucine in the polypeptide molecule at amino acid position 2903 in the numbering of SEQ ID NO: 6 corresponding to NS5-412, and comprising a dengue-1/dengue-2 chimera, wherein the dengue-1/dengue-2 chimera
comprises an adenine to guanine mutation at position 7311 in the numbering of SEO ID NO: 13.