Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.

Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.

The present invention aims at providing a mucosal vaccine composition that can be administered to an intraoral mucous membrane, ocular mucous membrane, ear mucous membrane, genital mucous membrane, pharyngeal mucous membrane, respiratory tract mucous membrane, bronchial mucous membrane, pulmonary mucous membrane, gastric mucous membrane, enteric mucous membrane, or rectal mucous membrane, that is useful as a prophylactic or therapeutic agent for infectious diseases or cancers, and is capable of safely and effectively inducing the systemic immune response and mucosal immune response. The present invention provides a mucosal vaccine composition to be administered to at least one mucous membrane selected from the group consisting of a human or animal intraoral mucous membrane, ocular mucous membrane, ear mucous membrane, genital mucous membrane, pharyngeal mucous membrane, respiratory tract mucous membrane, bronchial mucous membrane, pulmonary mucous membrane, gastric mucous membrane, enteric mucous membrane, and rectal mucous membrane, containing: at least one antigen; and as an adjuvant, a lipopolysaccharide derived from at least one gram-negative bacterium selected from the group consisting of Serratia, Leclercia, Rahnella, Acidicaldus, Acidiphilium, Acidisphaera, Acidocella, Acidomonas, Asaia, Belnapia, Craurococcus, Gluconacetobacter, Gluconobacter, Kozakia, Leahibacter, Muricoccus, Neoasaia, Oleomonas, Paracraurococcus, Rhodopila, Roseococcus, Rubritepida, Saccharibacter, Stella, Swaminathania, Teichococcus, Zavarzinia, Pseudomonas, Achromobacter, Bacillus, Methanoculleus, Methanosarcina, Clostridium, Micrococcus, Flavobacterium, Pantoea, Acetobacter, Zymomonas, Xanthomonas, and Enterobacter, or a salt thereof.

The present invention aims at providing a mucosal vaccine composition that can be administered to an intraoral mucous membrane, ocular mucous membrane, ear mucous membrane, genital mucous membrane, pharyngeal mucous membrane, respiratory tract mucous membrane, bronchial mucous membrane, pulmonary mucous membrane, gastric mucous membrane, enteric mucous membrane, or rectal mucous membrane, that is useful as a prophylactic or therapeutic agent for infectious diseases or cancers, and is capable of safely and effectively inducing the systemic immune response and mucosal immune response. The present invention provides a mucosal vaccine composition to be administered to at least one mucous membrane selected from the group consisting of a human or animal intraoral mucous membrane, ocular mucous membrane, ear mucous membrane, genital mucous membrane, pharyngeal mucous membrane, respiratory tract mucous membrane, bronchial mucous membrane, pulmonary mucous membrane, gastric mucous membrane, enteric mucous membrane, and rectal mucous membrane, containing: at least one antigen; and as an adjuvant, a lipopolysaccharide derived from at least one gram-negative bacterium selected from the group consisting of Serratia, Leclercia, Rahnella, Acidicaldus, Acidiphilium, Acidisphaera, Acidocella, Acidomonas, Asaia, Belnapia, Craurococcus, Gluconacetobacter, Gluconobacter, Kozakia, Leahibacter, Muricoccus, Neoasaia, Oleomonas, Paracraurococcus, Rhodopila, Roseococcus, Rubritepida, Saccharibacter, Stella, Swaminathania, Teichococcus, Zavarzinia, Pseudomonas, Achromobacter, Bacillus, Methanoculleus, Methanosarcina, Clostridium, Micrococcus, Flavobacterium, Pantoea, Acetobacter, Zymomonas, Xanthomonas, and Enterobacter, or a salt thereof.

The present disclosure provides inter alia compositions that comprise therapeutic agents (e.g., live attenuated viral antigens, therapeutic proteins, etc.) and a lipid component. The lipid component may comprise or consist of different types of lipid or lipids as described herein. In some embodiments the therapeutic agents are thermolabile. The present disclosure also provides methods for preparing compositions, including the aforementioned compositions (e.g., melt methods and spray injection methods among others).

The present disclosure provides inter alia compositions that comprise therapeutic agents (e.g., live attenuated viral antigens, therapeutic proteins, etc.) and a lipid component. The lipid component may comprise or consist of different types of lipid or lipids as described herein. In some embodiments the therapeutic agents are thermolabile. The present disclosure also provides methods for preparing compositions, including the aforementioned compositions (e.g., melt methods and spray injection methods among others).

An object of the present invention is to provide an adjuvant for a mucosal vaccine with high safety that induces a sufficient immune response in a mucosal membrane. According to the present invention, an adjuvant for a mucosal vaccine containing a protein complex composed of hemagglutinin (HA) subcomponents HA1 and HA2, and mutant subcomponent HA3 of botulinum toxin is provided.

The present disclosure relates to field of lyophilized/freeze-dried viral combination composition/formulation and methods for manufacturing and obtaining the composition comprising at least three live attenuated virus selected from a group of Coronavirus, Measles virus and Rubella virus; and stabilizers comprising of at least one carbohydrate, at least one amino acid and at least one hydrolyzed protein. The said lyophilized/freeze-dried viral combination composition/formulation is a vaccine composition that preserves the desired characteristics of each virus, including stability and immunogenicity. The composition can be safely administered subcutaneously as a combination vaccine composition such that the immunogenicity of each of the measles, rubella and SARS-CoV-2 is not inferior to that observed for each of the three viruses when administered as individual vaccines and is found to be equivalent or improved as compared to immunogenicity of SARS-CoV-2 vaccine given intranasally. The purification process is devoid of chromatography steps.

The present disclosure relates to field of lyophilized/freeze-dried viral combination composition/formulation and methods for manufacturing and obtaining the composition comprising at least three live attenuated virus selected from a group of Coronavirus, Measles virus and Rubella virus; and stabilizers comprising of at least one carbohydrate, at least one amino acid and at least one hydrolyzed protein. The said lyophilized/freeze-dried viral combination composition/formulation is a vaccine composition that preserves the desired characteristics of each virus, including stability and immunogenicity. The composition can be safely administered subcutaneously as a combination vaccine composition such that the immunogenicity of each of the measles, rubella and SARS-CoV-2 is not inferior to that observed for each of the three viruses when administered as individual vaccines and is found to be equivalent or improved as compared to immunogenicity of SARS-CoV-2 vaccine given intranasally. The purification process is devoid of chromatography steps.

Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.