Nanoemulsion respiratory syncytial virus (RSV) subunit vaccine
Inventors
Fattom, Ali I. • Hamouda, Tarek • Bitko, Vira • Baker, Jr., James R.
Assignees
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Publication Number
US-10596251-B2
Publication Date
2020-03-24
Expiration Date
Abstract
The present application relates to the field of immunology, in particular, a vaccine composition of respiratory syncytial virus (RSV) surface proteins, Fusion (F) and Glycoprotein (G) proteins subunit vaccine preferentially mixed with the immune cell targeting and enhancer, nanoemulsion to induce a protective immune response and avoid vaccine-induce disease enhancement.
Core Innovation
The disclosed invention relates to a method for inducing an increased level of acquired immunity against diseases caused by respiratory syncytial viruses (RSV) in a subject. The method administers a first effective amount of a vaccine comprising at least one isolated RSV antigen together with an immune-enhancing nanoemulsion or a dilution thereof. The isolated RSV antigen is selected from an isolated RSV F protein, an isolated RSV G protein, an isolated antigenic fragment of an RSV F protein, an isolated antigenic fragment of an RSV G protein, or any combination thereof.
The vaccine includes an immune-enhancing nanoemulsion comprising droplets having an average size of about 1000 nm or less, an aqueous phase, at least one oil, at least one surfactant, and at least one organic solvent. The isolated RSV antigen is comprised within the nanoemulsion. A second boost amount of the same vaccine is then administered, where the level of acquired immunity is increased as compared to a subject that has not been administered the nanoemulsion.
The problem being addressed is inducing protective acquired immunity to RSV while avoiding vaccine-enhanced disease or immunopotentiation. The disclosed formulations are described as promoting protective immunity and, in example data discussed, are associated with reduced airway hyperreactivity and reduced immunopotentiation. The immune outcomes include protective immune response patterns, optionally including Th1/Th2/Th17.
Claims Coverage
The document provides one independent claim covering an RSV acquired-immunity induction method based on an antigen-containing immune-enhancing nanoemulsion with droplets of about 1000 nm or less, followed by a second boost with the same vaccine. Dependent claims refine key inventive aspects including antigen source/variant, droplet size thresholds, nanoemulsion composition constraints, immune-response type, and boost timing.
Antigen-containing immune-enhancing nanoemulsion with ≤1000 nm droplets
Administering to a subject a first effective amount of a vaccine comprising at least one isolated RSV antigen selected from an isolated RSV F protein, an isolated RSV G protein, an isolated antigenic fragment of RSV F protein, an isolated antigenic fragment of RSV G protein, or any combination thereof, together with an immune-enhancing nanoemulsion having droplets with an average size of about 1000 nm or less, an aqueous phase, at least one oil, at least one surfactant, and at least one organic solvent, wherein the at least one isolated RSV antigen is comprised within the nanoemulsion.
Boosting with the same nanoemulsion-containing vaccine to increase acquired immunity
Administering to the subject a second boost amount of the same vaccine, wherein the level of acquired immunity is increased as compared to a subject that has not been administered the nanoemulsion.
Droplet average diameter selection for the nanoemulsion
Performing the method using nanoemulsion droplets whose average diameter is selected from specified ranges/thresholds as further constrained beyond the baseline of about 1000 nm or less.
Component-constrained nanoemulsion formulation
Performing the method using a nanoemulsion whose composition includes specified ranges of aqueous phase, oil, organic solvent, and surfactant.
HRSV-L19 as the source of the isolated RSV antigen
Further limiting the isolated RSV antigen such that the isolated RSV antigen is taken from a human respiratory syncytial virus HRSV-L19.
Immune response outcome types induced by the nanoemulsion administration
Including administering an immune-enhancing nanoemulsion to induce a Th1, Th2, Th17, or combined immune response in the subject.
Overall, the claim set centers on delivering isolated RSV F/G antigens inside an immune-enhancing nanoemulsion with droplets of about 1000 nm or less, followed by a second boost with the same vaccine to increase acquired immunity compared to no nanoemulsion administration. Dependent claims further narrow the invention by specifying droplet diameter selection, nanoemulsion component constraints, HRSV-L19 antigen selection, immune response types (Th1/Th2/Th17), and regimen timing refinements.
Stated Advantages
Induces an increased level of acquired immunity against diseases caused by respiratory syncytial viruses (RSV) compared to a subject that has not been administered the nanoemulsion.
Promotes protective immunity while avoiding vaccine-enhanced disease or immunopotentiation.
Optionally supports Th1/Th2/Th17 immune response patterns.
Documented Applications
Inducing acquired immunity against diseases caused by respiratory syncytial viruses (RSV) in a subject.
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