IP Library Granted Patent US 9,408,901
Granted Patent B2
US 9,408,901 · App. 14/076,034 · Granted Aug 9, 2016

Compositions, methods and uses for dengue virus serotype-4 constructs

Inventors: Jill A. Livengood (Fort Collins, CO); Claire Y. Huang (Fort Collins, CO); Timothy D. Powell (Fort Collins, CO); Dan T. Stinchcomb (Fort Collins, CO); Jorge Osorio (Mount Horeb, WI)
Assignees: TAKEDA VACCINES, INC; THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY OF HEALTH & HUMAN SERVICES
A61K39/12A61K2039/5254A61K2039/5256A61K2039/53A61K2039/70C12N2770/24121C12N2770/24122C12N2770/24134
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Quick Facts
Patent No.
US 9,408,901
App. No.
14/076,034
Granted
Aug 9, 2016
Kind
B2
Abstract

Embodiments herein report compositions, methods and uses for dengue-4 (DENV-4) virus constructs. Some embodiments concern a composition that includes, but is not limited to, DENV-4 virus constructs alone or in combination with other constructs, can be used in a vaccine composition to induce an immune response in a subject. In certain embodiments, compositions can include constructs of more than one serotypes of dengue virus, such as dengue-1 virus, dengue-2 virus, or dengue-3 virus in combination with DENV-4 virus constructs disclosed herein. In other embodiments, DENV-4 constructs disclosed herein can be combined in a composition with other flavivirus constructs to generate a vaccine against more than one flavivirus. Other embodiments provide methods and uses for DENV-4 virus constructs in vaccine compositions that when administered to a subject induce an immune response in the subject against DENV-4 that is improved by modified constructs compared to other vaccine compositions.

Claims (27)

1. A nucleic acid molecule comprising a chimeric flavivirus construct comprising nucleic acid sequences encoding nonstructural proteins and one or more structural proteins from a live, attenuated dengue-2 virus and at least encoding one or more structural proteins from a second dengue virus, the second flavivirus is selected from the group dengue-1, dengue-3 or dengue-4 virus wherein the chimeric construct further comprises one or more mutations comprising, a mutation in an envelope (E) protein at an amino acid position synonymous of dengue 4 to amino acid 417 when the E protein is from the second flavivirus wherein the mutation in the envelope (E) protein at the position synonymous to amino acid 417 changes glutamic acid to a positively charged residue; a mutation in the capsid protein at an amino acid position synonymous to amino acid 107 in the attenuated dengue-2 wherein the mutation in the capsid (C) protein at the position synonymous to amino acid 107 changes cysteine to an aromatic amino acid residue in the attenuated dengue-2, and a mutation in NS4A at an amino acid position synonymous to amino acid position 17 in the attenuated dengue-2.

2. The nucleic acid molecule according to claim 1 , wherein the second flavivirus is dengue-4.

3. The nucleic acid molecule according to claim 1 , wherein the position synonymous to 417 is a lysine instead of the glutamic acid in the at least second flavivirus.

4. The nucleic acid molecule according to claim 1 , wherein the nucleic acid molecule comprises the mutation in the capsid (C) protein at a position synonymous to amino acid 107 changes cysteine to an aromatic amino acid residue; a mutation in the envelope (E) protein at the position synonymous to amino acid 417 changes glutamic acid to a positively charged residue; and a mutation in NS4A at an amino acid position synonymous to amino acid position 17 in the attenuated dengue-2.

5. The nucleic acid molecule according to claim 1 , wherein the aromatic amino acid at the position synonymous to amino acid 107 is a tyrosine.

6. The nucleic acid molecule according to claim 1 , wherein the mutation in the NS4A protein at the position synonymous to amino acid 17 changes methionine to a basic amino acid.

7. The nucleic acid molecule according to claim 1 , wherein the mutation in the NS4A protein at a position synonymous to amino acid 17 changes methionine to a leucine.

8. The nucleic acid molecule according to claim 1 , wherein the live, attenuated dengue-2 contains a mutation at position 57 in the 5′NCR, a mutation at position 53 of NS1 and a mutation at position 250 of NS3.

9. The nucleic acid molecule according to claim 1 , wherein the live, attenuated dengue-2 contains a mutation at position 53 of NS1 and a mutation at position 250 of NS3.

10. The nucleic acid molecule according to claim 2 , wherein amino acid positions 102-106 of attenuated dengue-2 are substituted with synonymous amino acids of a dengue-4 virus in these positions.

11. The nucleic acid molecule according to claim 1 , further comprising a structural protein from a third different flavivirus.

12. The nucleic acid molecule according to claim 11 , wherein the third different flavivirus is selected from the group consisting of West Nile virus, Japanese encephalitis virus, St. Louis encephalitis virus, tickborne encephalitis virus, and yellow fever virus.

13. A composition comprising one or more nucleic acid molecules according to claim 1 , and a pharmaceutically acceptable carrier.

14. The composition according to claim 13 , wherein the composition further comprises additional dengue-dengue chimeric constructs.

15. The composition according to claim 13 , wherein the composition is part of a divalent, trivalent or tetravalent dengue virus composition.

16. The composition according to claim 13 , wherein the composition further comprises other live, attenuated flaviviruses.

17. A method of inducing an immune response to dengue virus in a subject comprising administering the composition of claim 13 to the subject.

18. The method according to claim 17 , wherein an immune response to at least one of dengue-1, dengue-2, dengue-3 and dengue-4 is induced in the subject.

19. A kit comprising one or more compositions according to claim 13 and a container.

20. A live, attenuated virus comprising the nucleic acid molecule according to claim 1 .

21. A live, attenuated dengue-4 chimera comprising DENVax4e, DENVax4i or DENVax4h.

22. The chimera according to claim 21 , wherein the chimera comprises SEQ ID NO: 22, SEQ ID NO:9, or SEQ ID NO: 24.

23. A composition comprising one or more nucleic acid chimeras according to claim 21 , and a pharmaceutically acceptable carrier.

24. A method of inducing an immune response to dengue virus in a subject comprising administering the composition of claim 23 to the subject.

25. The nucleic acid molecule according to claim 2 , wherein dengue-4 is from strain 1036.

26. The nucleic acid molecule according to claim 1 , wherein the live, attenuated dengue-2 virus comprises a mutated PDK-53 backbone.

27. The live, attenuated virus of claim 20 , wherein the live, attenuated virus is part of an immunogenic composition against two or more dengue virus serotypes.

Assignments (7)
CHANGE OF ASSIGNEE ADDRESS RECORDED ON REEL 033575, FRAME 0662 Recorded Aug 29, 2019
From: TAKEDA VACCINES, INC.
To: TAKEDA VACCINES, INC.
Reel/Frame 050234/0929 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2017
From: STINCHCOMB, DAN T.; LIVENGOOD, JILL A.; POWELL, TIMOTHY D.
To: INVIRAGEN, INC.
Reel/Frame 043885/0899 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2017
From: HUANG, CLAIRE Y
To: THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 043885/0922 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2017
From: LIVENGOOD, JILL A.; STINCHCOMB, DAN T.; OSORIO, JORGE
To: INVIRAGEN, INC.
Reel/Frame 043885/0933 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2017
From: HUANG, CLAIRE Y
To: THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 043885/0946 →
CONFIRMATORY LICENSE Recorded Nov 24, 2015
From: INVIRAGEN, INC.
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 037155/0288 →
MERGER AND CHANGE OF NAME Recorded Aug 20, 2014
From: INVIRAGEN, INC.; TAKEDA VACCINES (MONTANA), INC.; TAKEDA VACCINES, INC.
To: TAKEDA VACCINES, INC.
Reel/Frame 033575/0662 →
Continuity (3)
Provisional Application 61724190 · Nov 8, 2012
Provisional Application 61788536 · Mar 15, 2013
Related Publication 20140134205A1 · May 15, 2014