Compositions and methods of manufacturing trivalent filovirus vaccines
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Publication Number
US-11433129-B2
Publication Date
2022-09-06
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 a stable immunogenic composition capable of eliciting a robust and durable immune response. The composition includes at least one antigen comprising a viral glycoprotein, and at least one adjuvant comprising sucrose fatty acid sulphate esters. The adjuvant is a nano-emulsion adjuvant that is mixed with the antigen prior to lyophilization.
A further aspect of the invention describes a stable immunogenic composition that uses at least one nano-emulsion adjuvant. The nano-emulsion adjuvant is lyophilized and can be reconstituted immediately prior to use with an antigen, thereby supporting use after storage while maintaining immunogenicity at the time of administration.
The invention also addresses a formulation approach for more than one virus. It provides a stable immunogenic composition for eliciting a robust and durable immune response to more than one virus by using at least two antigens, wherein each antigen is specific to a different virus, and combining the antigen(s) with a nano-emulsion adjuvant comprising sucrose fatty acid sulphate esters prior to lyophilization. The adjuvant does not contain alum, and the multivalent formulation is described as compatible with multivalent mixtures.
The documented examples focus on thermostabilized filovirus vaccine formulations based on recombinant filovirus glycoproteins and a nano-emulsion adjuvant described as CoVaccine-HT. The antigen(s) and adjuvant are co-lyophilized, followed by reconstitution immediately before use, with the resulting formulations assessed for formulation compatibility/stability and immunogenicity/protective efficacy in rodents and non-human primates.
Claims Coverage
The partial claim set includes three independent claims covering lyophilized stable immunogenic compositions and a manufacturing concept using viral glycoprotein antigens with sucrose fatty acid sulphate ester nano-emulsion adjuvants, including immediate reconstitution and alum-free multi-virus formulations.
Lyophilized viral glycoprotein nano-emulsion adjuvant composition mixed prior to lyophilization
A stable, immunogenic composition comprising at least one viral glycoprotein antigen and at least one adjuvant comprising sucrose fatty acid sulphate esters, wherein the adjuvant is a nano-emulsion adjuvant mixed with the antigen prior to lyophilization.
Lyophilized nano-emulsion adjuvant reconstitutable immediately prior to use
A stable immunogenic composition comprising at least one nano-emulsion adjuvant, wherein the nano-emulsion adjuvant is lyophilized and can be reconstituted immediately prior to use with an antigen.
Manufacturing method for multi-virus composition using virus-specific antigens and alum-free nano-emulsion sucrose fatty acid sulphate esters prior to lyophilization
A method of manufacturing a stable immunogenic composition for more than one virus comprising at least two antigens each specific to a different virus, providing at least one adjuvant comprising sucrose fatty acid sulphate esters formulated as a nano-emulsion combined with the antigen prior to lyophilization, wherein the adjuvant does not contain alum.
Across the independent claims, the central claim coverage is directed to lyophilized stable immunogenic compositions and corresponding manufacturing concepts that use viral glycoprotein antigens together with sucrose fatty acid sulphate ester nano-emulsion adjuvants, including configurations where the nano-emulsion adjuvant is immediately reconstitutable and where alum is excluded for multi-virus formulations.
Stated Advantages
Capable of eliciting a robust and durable immune response.
Thermostabilized/lyophilized formulations with immediate reconstitution prior to use.
Supports robust and durable immune response to more than one virus using multi-antigen formulations.
Nano-emulsion adjuvant does not contain alum.
Documented Applications
Thermostabilized filovirus vaccine formulations comprising recombinant filovirus glycoproteins (including EBOV, MARV, and SUDV) formulated with a nano-emulsion adjuvant and co-lyophilized with the antigen(s) for reconstitution immediately before use.
Protection and immunogenicity assessment in rodents.
Protection and immunogenicity assessment in non-human primates.
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