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Compositions and methods of dengue virus chimeric constructs for use in vaccines

A kind of dengue fever virus, dengue fever technology, applied in the direction of drug combination, biochemical equipment and methods, virus, etc., can solve the problems of public health efforts such as difficulty in complete vaccine coverage

Active Publication Date: 2021-06-18
TAKEDA VACCINES INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Multiple immunizations make complete vaccine coverage difficult both for public health efforts in dengue virus endemic countries and for travelers

Method used

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  • Compositions and methods of dengue virus chimeric constructs for use in vaccines
  • Compositions and methods of dengue virus chimeric constructs for use in vaccines
  • Compositions and methods of dengue virus chimeric constructs for use in vaccines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] In some exemplary methods, compositions for producing what are referred to herein as "master virus species (MVS)" are disclosed. These compositions may be derived from one or more live attenuated dengue viruses, such as DEN-1, DEN-2, DEN-3 and DEN-4. In certain methods, compositions may be derived from one or more live attenuated dengue viruses, including, but not limited to, the specific constructs disclosed herein referred to as DENVax-1, DENVax-2, DENVax-3, and DENVax-4 things. Among other exemplary methods, strategies for generating and characterizing these compositions are provided. In other embodiments, tetravalent dengue virus formulations and genetic and phenotypic characterization of these formulations are provided.

[0110] Production and analysis of pre-primary DENVax virus

[0111]Certain procedures are performed to generate pre-primary dengue species, such as a series of amplifications and purifications of dengue viruses (eg DENVax). First, P1 (passage ...

Embodiment 2

[0120] In some exemplary methods, compositions of master virus seeds, working virus seeds, and bulk virus seeds and their genetic and phenotypic characterizations are described. These compositions are provided for the manufacture of clinical material and eventual commercial vaccine supply. Continuous plaque purification and whole genome sequence analysis are incorporated into the manufacturing process to ensure that the composition of the vaccine species has optimal safety and genetic stability for the manufacture of clinical trial material.

[0121] Production and manufacturing quality control of MVS, WVS and BVS

[0122] In some studies, four DENVax MVS were generated by expansion of pre-primary P7 species in approved Vero cells. In other studies, MVS was used in cell culture to prepare large quantities of WVS. In addition, DENVax's BVS feedstock was expanded from WVS and formulated into a quadrivalent drug mixture for human clinical trials. Quality control of product rel...

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PUM

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Abstract

Embodiments herein report on the composition, use and manufacture of dengue virus constructs and live attenuated dengue virus. Some embodiments relate to compositions including, but not limited to, tetravalent dengue virus compositions. In certain embodiments, the composition may comprise a construct of one or more serotypes of dengue virus, such as dengue-1 (DEN-1) virus, dengue-2 (DEN-2) virus, dengue-3 ( DEN-3) virus or Dengue-4 (DEN-4) virus constructs. In other embodiments, the constructs disclosed herein may be combined in compositions to generate vaccines against more than one or more dengue virus constructs that may or may not be passaged sequentially in mammalian cells .

Description

[0001] priority [0002] This PCT application claims priority to U.S. Provisional Application No. 61 / 800,204, filed March 15, 2013. This application is hereby incorporated by reference in its entirety for all purposes. [0003] federally funded research and development [0004] Some embodiments disclosed herein were supported in part by the National Institutes of Health under grant number R43 AI08429-01. The US Government has certain rights in the practice of this invention. technical field [0005] Embodiments herein report compositions, methods, uses and manufacturing procedures of dengue virus constructs and vaccine compositions thereof. Some embodiments relate to compositions including, but not limited to, chimeric flavivirus constructs that are useful in vaccine compositions alone or in combination with other constructs. In certain embodiments, the composition may comprise constructs of more than one dengue virus serotype, such as dengue-1 (DEN-1) virus, dengue-2 (DEN...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/12
CPCA61K39/12A61K2039/5254A61K2039/70C12N2770/24134C12N2770/24143A61K31/7048C12N2770/24162C07K2319/00A61P31/14A61K31/713C12N2770/24122A61K38/162A61P31/12A61P37/04Y02A50/30C07K14/005C12N2770/24161C12N2770/24141C07K14/1825C07K19/00C12N15/09C12N15/8613
Inventor 丹·T·斯廷奇科姆克莱尔·凯尼理查德·M·凯尼吉尔·A·利文格德
Owner TAKEDA VACCINES INC