Compositions and methods of manufacturing trivalent filovirus vaccines
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Publication Number
US-11771757-B2
Publication Date
2023-10-03
Expiration Date
Abstract
Disclosed is a stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen consisting of a filovirus glycoprotein and at least one nano-emulsion adjuvant which are co-lyophilized and can be reconstituted immediately prior to use. Also disclosed is a vaccine composition comprising at least two antigens, wherein each antigen is specific to a different genus of filovirus and which also comprises at least one nano-emulsion adjuvant.
Core Innovation
The invention provides stable recombinant filovirus vaccine compositions and formulations based on native trimeric filovirus glycoprotein subunit antigens from EBOV, MARV, and SUDV. The compositions are produced in stably transformed Drosophila S2 cells and are combined with the nano-emulsion adjuvant CoVaccine-HT™ and optionally CoVaccine-HT′.
A central concept is co-lyophilization of antigen(s) with nano-emulsion adjuvant, optionally without alum, followed by immediate reconstitution prior to use. This approach yields thermostabilized products that retain immunogenicity.
The document describes formulations including trivalent mixtures in the same vial that can be co-lyophilized with adjuvant and reconstituted immediately prior to use while maintaining comparable immunogenicity to co-injection. Stability is assessed under formulation variables such as salt, pH, and surfactant for MARV and SUDV, supported by analytical methods including SEC and SEC-MALS.
Claims Coverage
The partial content includes three independent claims. The inventive features span stable, immunogenic compositions defined by antigen/adjuvant pairing and co-lyophilized immediate reconstitution, compositions with at least two filovirus-genera-specific glycoprotein antigens and nano-emulsion adjuvant, and a manufacturing method requiring co-lyophilization and alum-free sucrose fatty acid sulphate ester adjuvant with immediate reconstitution prior to use.
Co-lyophilized viral glycoprotein antigen with sucrose fatty acid sulphate ester adjuvant for immediate reconstitution
A stable, immunogenic composition comprising at least one antigen comprising a viral glycoprotein and at least one adjuvant comprising sucrose fatty acid sulphate esters, wherein the at least one antigen and the at least one adjuvant are co-lyophilized and reconstituted immediately prior to use.
Filovirus-genus-specific viral glycoprotein antigens with nano-emulsion adjuvant
A stable immunogenic composition comprising at least two antigens, wherein each antigen is a viral glycoprotein specific to a different genus of filovirus and at least one nano-emulsion adjuvant.
Manufacturing via co-lyophilization of antigens with alum-free sucrose fatty acid sulphate ester adjuvant and immediate reconstitution
A method of manufacturing a stable immunogenic composition comprising at least two antigens, wherein each antigen is specific to a different virus, and providing at least one adjuvant comprising sucrose fatty acid sulphate esters, wherein the at least one antigen and the at least one adjuvant are co-lyophilized and reconstituted immediately prior to use, and further wherein the at least one adjuvant does not contain alum.
Across the independent claims, protection is directed to stable, immunogenic filovirus vaccine compositions defined by viral glycoprotein antigens paired with sucrose fatty acid sulphate ester nano-emulsion adjuvant, with antigen and adjuvant co-lyophilized and reconstituted immediately prior to use, including compositions with multi-genera filovirus glycoproteins and an alum-free manufacturing constraint.
Stated Advantages
Stable, immunogenic compositions capable of eliciting a robust and durable immune response.
Thermostabilized products retaining immunogenicity after the co-lyophilization and immediate reconstitution approach.
Trivalent mixtures in the same vial can be co-lyophilized with adjuvant and reconstituted immediately prior to use while maintaining comparable immunogenicity to co-injection.
Documented Applications
Use of stable recombinant filovirus vaccine compositions formulated with native trimeric filovirus glycoprotein subunit antigens (EBOV, MARV, SUDV) and nano-emulsion adjuvant, with supporting immunogenicity and efficacy evidence in mouse/guinea pig/NHP challenge models.
Development of more complex multivalent vaccines based on the described platform approach using co-lyophilization of antigen(s) with nano-emulsion adjuvant followed by immediate reconstitution prior to use.
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