Combination purified inactivated vaccine for flaviviruses

• US 10,086,061 B2
• Filed: 03/10/2016
• Issued: 10/02/2018
• Est. Priority Date: 03/11/2015
• Status: Active Grant

• Current Assignee: US Department of The Army (Government of the United States of America)
• Original Assignee: United States Of America As Represented By The Secretary Of The Army (Government of the United States of America)
• Inventors: Thomas, Stephen J., Eckels, Kenneth H., Putnak, Joseph R.
• Primary Examiner(s): Gill, Rachel B
• Application Number:
  US15/550,433
• Publication Number:
  US 20180021426A1
• Time in Patent Office: 936 Days
• CPC Class Codes: A61K 2039/5252 inactivated (killed)
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: C12N 2770/24034 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2770/24051 Methods of production or purification of viral material
• CPC Class Codes: C12N 2770/24134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2770/24151 Methods of production or purification of viral material
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Immunogenic compositions comprising one or more inactivated dengue viruses and one or more inactivated non-dengue flaviviruses and methods of making and using thereof are provided.

Claims

1. An immunogenic composition comprising one or more inactivated dengue viruses and one or more inactivated non-dengue flaviviruses, an adjuvant, and a pharmaceutically acceptable vehicle, wherein said non-dengue flaviviruses are selected from the group consisting of yellow fever virus (YFV) group viruses, Japanese encephalitis virus (JEV) group viruses, and Zika virus (ZIKV).

2. The immunogenic composition of claim 1, wherein the one or more inactivated dengue viruses are selected from the group consisting of an inactivated DENV-1, an inactivated DENV-2, an inactivated DENV-3, and an inactivated DENV-4.

3. The immunogenic composition of claim 1, wherein the one or more inactivated dengue viruses consist of an inactivated DENV-1, an inactivated DENV-2, an inactivated DENV-3, and an inactivated DENV-4.

4. The immunogenic composition according to claim 1, wherein said dengue virus is an inactivated DENV-1 produced from deposited DENV-1 strain having ATCC accession number VR-2649.

5. The immunogenic composition according to claim 1, wherein said dengue virus is an inactivated DENV-2 produced from deposited DENV-2 strain having ATCC accession number VR-2650.

6. The immunogenic composition according to claim 1, wherein said dengue virus is an inactivated DENV-3 produced from deposited DENV-3 strain having ATCC accession number VR-2654.

7. The immunogenic composition according to claim 1, wherein said dengue virus is an inactivated DENV-4 produced from deposited DENV-4 strain having ATCC accession number VR-2651.

8. The immunogenic composition according to claim 1, wherein the one or more inactivated non-dengue flaviviruses are selected from the group consisting of yellow fever group viruses and Japanese encephalitis group viruses.

9. The immunogenic composition according to claim 1, wherein the one or more inactivated non-dengue flaviviruses are selected from the group consisting of yellow fever virus (YFV), Japanese encephalitis virus (JEV), and West Nile virus (WNV).

10. The immunogenic composition according to claim 1, wherein the one or more inactivated non-dengue flaviviruses are yellow fever virus (YFV) and Japanese encephalitis virus (JEV).

11. The immunogenic composition according to claim 1, wherein the one or more inactivated non-dengue flavivirus is Zika virus (ZIKV).

12. The immunogenic composition according to claim 1, wherein the one or more inactivated dengue viruses are present in an immunologically effective amount and/or the one or more inactivated non-dengue flaviviruses are present in an immunologically effective amount.

13. The immunogenic composition according to claim 1, wherein the one or more inactivated dengue viruses are purified and/or the one or more inactivated non-dengue flaviviruses are purified.

14. A method of producing antibodies against a dengue virus and a non-dengue flavivirus in a subject, which comprises administering to the subject the immunogenic composition according to claim 1.

15. The method according to claim 14, wherein the immunogenic composition is administered on Day 0 and on Day 28.

16. The method according to claim 14, wherein the administration is by intramuscular injection.

17. A medicament for producing antibodies against a dengue virus and a non-dengue flavivirus in a subject, which comprises the immunogenic composition according to claim 1.

18. A method of inducing an immune response in a subject, which comprises administering the immunogenic composition according to claim 1 to the subject.

19. The immunogenic composition according to claim 1, wherein the one or more inactivated dengue viruses and the one or more inactivated non-dengue flaviviruses, wherein when said one or more inactivated non-dengue flaviviruses are selected from the group consisting of yellow fever virus (YFV) group viruses and Japanese encephalitis virus (JEV) group viruses, do not result in immunologic interference when administered to a subject.

20. An immunogenic composition comprising an inactivated DENV-1, an inactivated DENV-2, an inactivated DENV-3, an inactivated DENV-4, and one or more inactivated non-dengue flaviviruses selected from the group consisting of yellow fever virus (YFV) group viruses and Japanese encephalitis virus (JEV) group viruses, an adjuvant, and a pharmaceutically acceptable vehicle, wherein the inactivated dengue viruses and the one or more inactivated non-dengue flaviviruses do not result in immunologic interference when administered to a subject.