Solanesol vaccine adjuvants and methods of preparing same
Inventors
Assignees
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Publication Number
US-12285483-B2
Publication Date
2025-04-29
Expiration Date
Abstract
This disclosure describes the use of solanesol as an adjuvant in vaccine compositions, as well as related prophylactic and therapeutic methods. Solanesol may be used to replace squalene in vaccine compositions with similar or superior immunostimulatory effects. Solanesol, which is solid at room temperature, may be formulated for use in vaccine compositions by heating above its melting temperature in an aqueous solution to form a dispersion.
Core Innovation
An immunostimulatory composition is disclosed that includes solanesol at an amount sufficient to stimulate the immune system of a subject. The solanesol is provided in two physical forms that depend on the melting point of solanesol, namely as a solid lipid nanoparticle below the melting point and as an emulsion above the melting point.
The disclosure further describes the use of solanesol in oil-in-water emulsions or aqueous dispersions, including solid lipid nanoparticle formats such as nanostructured lipid carriers and solid lipid nanoparticles. Formulations may include one or more surfactants, such as a hydrophilic surfactant including Pluronic F68 and a hydrophobic surfactant including DMPC or poloxamer 188, together with optional tonicity agents and optional antioxidants.
The disclosed approach is supported by comparative stability and immunogenicity evidence. Solanesol-containing emulsions are described as showing comparable or increased in vitro innate immune stimulation and in vivo immune responses in mice compared to squalene, including rH5-specific IgG/IgG1/IgG2c, functional HAI antibodies, T-cell IFN-γ responses, plasmablast counts, and maintained physiochemical stability during refrigerated storage with maintained particle size.
Claims Coverage
The partial content includes one independent claim. It specifies solanesol as an immunostimulatory agent in two physical forms that are determined by solanesol’s melting point, and it is further refined by dependent features that constrain formulation components and stability/response characteristics.
Temperature-dependent solanesol physical forms for immunostimulation
An immunostimulatory composition comprising solanesol at an amount sufficient to stimulate the immune system of a subject, wherein the solanesol is in the form of a solid lipid nanoparticle below a melting point of solanesol and in the form of an emulsion above the melting point of solanesol.
Across the provided claim set, the core inventive concept is the use of solanesol as an immunostimulatory composition in temperature-dependent physical forms (solid lipid nanoparticles below the melting point and emulsions above the melting point), with dependent claim refinements directed to specific formulation and stability-related constraints and to the immune response context.
Stated Advantages
Solanesol emulsions show comparable or increased in vitro innate immune stimulation versus squalene.
Solanesol emulsions provide comparable or increased in vivo immune responses versus squalene, including antibody and T-cell responses.
Solanesol formulations show comparable physiochemical stability during refrigerated storage, with maintained particle size.
Documented Applications
Use of solanesol-containing immunostimulatory compositions as vaccine adjuvants in formulations evaluated in comparison to squalene, including responses measured using rH5-specific immune readouts (IgG/IgG1/IgG2c, functional HAI antibodies, T-cell IFN-γ responses, and plasmablast counts) in mice.
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