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Compositions and methods for making trivalent linear virus vaccines

A technology for compositions and viruses, applied in the directions of biochemical equipment and methods, multivalent vaccines, viruses, etc., can solve the problem of unproven vaccine nanoemulsion adjuvant freeze-drying to maintain immunogenicity, and co-lyophilization of nanoemulsion mixtures has not been confirmed. And other issues

Pending Publication Date: 2022-04-08
SOLIGENIX INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Lyophilization of nanoemulsions has been performed before, but lyophilization of vaccine nanoemulsion adjuvants has not been demonstrated – maintaining immunogenicity after lyophilization
Similarly, co-lyophilization of nanoemulsion mixtures with one or more individual proteins has not been demonstrated

Method used

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  • Compositions and methods for making trivalent linear virus vaccines
  • Compositions and methods for making trivalent linear virus vaccines
  • Compositions and methods for making trivalent linear virus vaccines

Examples

Experimental program
Comparison scheme
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Embodiment

[0050] The following examples illustrate various embodiments of the invention and are not meant to limit the scope based on these examples.

[0051] Expression and purification of subunit proteins:

[0052]All antigens used in the studies described herein have been expressed in 1-5 L batches using stably transformed Drosophila cell lines in WAVE bioreactors (GE Lifesciences, Piscataway, NJ). The expression levels of all selected cell lines (for MARV-GP after two rounds of subcloning) have stabilized in the range of 10-100 mg / L. The GP subunits are then purified by a single-step immunoaffinity chromatography (IAC) for each individual protein using specific affinity columns (see figure 1 ). To date, more than 200 mg of EBOV GP (E-GP), 100 mg of MARV GP and 100 mg of SUDV GP have been produced with purity levels between 90-95% (based on SDS-PAGE). EBOV, SUDV and MARV GP were of high purity and showed good antigen specificity ( figure 2 ).

[0053] To establish the equivalen...

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Abstract

Disclosed are stable immunogenic compositions capable of eliciting a strong and long-lasting immune response, comprising at least one antigen consisting of a linear virus glycoprotein, and at least one nanoemulsion adjuvant, which can be co-lyophilized and can be reconstituted immediately prior to use. Also disclosed are vaccine compositions comprising at least two antigens wherein each antigen is specific for a different Firovirus genus, and the composition further comprises at least one nanoemulsion adjuvant.

Description

technical field [0001] The present invention relates to the field of recombinant vaccine compositions combined with freeze-dried nanoemulsion adjuvants. The invention also relates to methods of making and using the recombinant monovalent or multivalent vaccine compositions described herein. The present invention specifically describes novel compositions of antigen and nanoemulsion adjuvant that are co-lyophilized to produce a thermostable adjuvanted vaccine that is reconstituted with a pharmaceutically acceptable diluent immediately prior to use. In particular, the present invention relates to recombinant non-replicating vaccines of filoviruses and similar formulations comprising at least one viral glycoprotein antigen co-lyophilized with a nanoemulsion adjuvant. [0002] technical background [0003] Although human infection with filoviruses remains relatively infrequent compared with other viruses, the extreme virulence and risk of mortality of filoviruses make such infect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00A61K39/02A61K39/07A61K39/12A61K39/39
CPCA61P31/14A61K2039/55566A61K2039/55577C12N2760/14134A61K39/12A61K2039/55572A61K2039/70C12N2760/14234C12N2770/20034C12N2760/14122C12N2760/14222Y02A50/30A61K2039/575A61K39/295A61K39/39C12N2760/20034C12N7/00
Inventor O·多尼尼A·莱勒
Owner SOLIGENIX INC
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