Herpes simplex virus nanoemulsion vaccine
Inventors
Fattom, Ali I. • Simon, Jakub • Baker, Jr., James R. • Hamouda, Tarek • Bitko, Vira
Assignees
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Publication Number
US-11147869-B2
Publication Date
2021-10-19
Expiration Date
Abstract
The present application relates to the field of human immunology, in particular, a herpes simplex virus (HSV) vaccine. The subunit vaccine composition comprises isolated surface glycoproteins from herpes simplex viruses, fusion proteins or fragments thereof mixed in varied combination with a nanoemulsion, which is a potent immune enhancer.
Core Innovation
The invention relates to a mucosal HSV vaccine composition and a method for inducing immunity against herpes simplex viruses (HSV) by mucosally administering an effective amount of a nanoemulsion mucosal HSV vaccine composition to an individual. The composition essentially includes an immune enhancing nanoemulsion for mucosal administration with droplets having an average diameter of less than about 600 nm, an aqueous phase, a pharmaceutically acceptable oil, a pharmaceutically acceptable surfactant selected from Polysorbate 80, Polysorbate 20, or combinations thereof, an alcohol, and a cationic surfactant selected from cetylpyridinium chloride (CPC) or dioctyl dimethyl ammonium chloride.
The nanoemulsion includes a combination of an isolated HSV gD antigen and an isolated HSV gB antigen within the nanoemulsion. The HSV gD antigen is HSV-1 gD, HSV-2 gD, or an immunogenic fragment of HSV-1 gD or HSV-2 gD, and the HSV gB antigen is HSV-1 gB, HSV-2 gB, or an immunogenic fragment of HSV-1 gB or HSV-2 gB. The approach is directed to inducing immunity against HSV through combined mucosal delivery of these isolated surface glycoprotein antigens formulated in the specified nanoemulsion adjuvant.
The problem addressed is the need for an HSV vaccine that induces broad humoral and cellular immune responses after mucosal administration, including neutralizing antibodies and Th1/Th2/Th17 responses, with potential usefulness for drug-resistant HSV, including acyclovir-resistant HSV. The disclosed formulation also includes antigen localization in an oil droplet core and storage stability under defined temperature and humidity conditions.
Claims Coverage
The partial content provides one independent claim directed to mucosal administration of a nanoemulsion HSV vaccine composition. The main claim is centered on a nanoemulsion adjuvant having droplets less than about 600 nm combined with a specific antigen pair, with dependent claims further narrowing droplet size, antigen amount, stability, antigen format, and clinical use.
Mucosal nanoemulsion delivery for HSV immunity
A method for inducing immunity against herpes simplex viruses (HSV) comprising mucosally administering to an individual an effective amount of a nanoemulsion mucosal HSV vaccine composition consisting essentially of an immune enhancing nanoemulsion for mucosal administration, wherein the nanoemulsion comprises droplets having an average diameter of less than about 600 nm, an aqueous phase, a pharmaceutically acceptable oil, at least one surfactant selected from Polysorbate 80, Polysorbate 20, or a combination thereof, an alcohol, and a cationic surfactant selected from cetylpyridinium chloride (CPC) or dioctyl dimethyl ammonium chloride.
Combined isolated HSV gD and isolated HSV gB antigens in the nanoemulsion
A nanoemulsion mucosal HSV vaccine composition further consisting of a combination of an isolated HSV gD antigen and an isolated HSV gB antigen within the nanoemulsion, wherein the HSV gD antigen is HSV-1 gD, HSV-2 gD, or an immunogenic fragment of HSV-1 gD or HSV-2 gD, and the HSV gB antigen is HSV-1 gB, HSV-2 gB, or an immunogenic fragment of HSV-1 gB or HSV-2 gB.
Overall, the claim coverage centers on mucosal administration of an immune enhancing nanoemulsion with droplets under 600 nm and a defined composition of oil, alcohol, selected polysorbate surfactant, and CPC or dioctyl dimethyl ammonium chloride, combined with a defined antigen pair consisting essentially of isolated HSV gD and isolated HSV gB antigens. Dependent claims further specify droplet size, antigen amount, storage stability, recombinant antigen format, and prevention and/or treatment of infection caused by an acyclovir-resistant HSV strain.
Stated Advantages
Induces immunity against herpes simplex viruses (HSV) through mucosal administration of the nanoemulsion HSV vaccine composition.
Provides broad humoral and cellular immunity including neutralizing antibodies and Th1/Th2/Th17 responses.
Is applicable to prevention and/or treatment of infection caused by an acyclovir-resistant HSV strain.
Provides storage stability under defined temperature and relative humidity conditions.
Documented Applications
Preventing and/or treating infection caused by an acyclovir-resistant HSV strain.
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