Multi-CBV vaccine for preventing or treating type I diabetes
Inventors
Heikki, Hyöty • Knip, Mikael • Laitinen, Olli • Tolonen, Outi • Pulkki, Minna • Oikarinen, Sami • Honkanen, Hanna-Riikka • Lecouturier, Valérie • Almond, Jeffrey • Flodström-Tullberg, Malin
Assignees
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Publication Number
US-10258685-B2
Publication Date
2019-04-16
Expiration Date
Abstract
The invention is directed to a vaccine comprising: i) coxsackie B virus CBV1 and CBV2, and ii) at least one coxsackie B virus selected from CBV3, CBV4, CBV5 and CBV6. The CBVs are present in the vaccine in inactivated form, in the form of a component of the virus or as an antibody against the virus. The vaccine is effective in preventing and treating type 1 diabetes. So is an anti-coxsackie B virus composition provided.
Core Innovation
The invention describes a multi-coxsackie B virus (CBV) vaccine/cocktail intended for preventing and treating type 1 diabetes (T1D). The document frames a need to address CBV risk across serotypes when inducing protective immunity related to T1D.
The core concept includes using multiple CBVs in a single composition to achieve pan-CBV protection. The document explicitly proposes a pan-CBV concept covering CBV1–CBV6, and it also describes alternative forms for the immune-inducing composition, including inactivated whole virus, subunits, virus-like particles (VLPs), or antibodies/passive immunization.
Supporting evidence in the document includes seroneutralization cohort analyses assessing odds ratios and time-window effects around autoantibody seroconversion (AAB+), with emphasis on CBV1 and CBV2 risk within a 6–0 months window and related population attributable risk (PAR) calculations. The document further describes mouse protection studies with an inactivated CBV1 vaccine showing reduced viremia and pancreatic infection after challenge, and a SOCS-1 transgenic NOD mouse model in which CBV1 is linked to diabetes via beta-cell destruction with dose-dependent incidence.
Claims Coverage
The partial content includes two independent claims, each describing a method of inducing an immune response to CBV. Both independent claims share the same core inventive composition: CBV1 and CBV2 plus at least one of CBV3/CBV4/CBV5, while excluding CBV6, with antigen forms limited to inactivated, subunit, or virus-like particle (VLP).
CBV immune response composition for pregnant woman excluding CBV6
A method of inducing an immune response to CBV in a pregnant woman by administering an effective amount of a composition comprising CBV1 and CBV2 in inactivated form or in the form of a subunit or a virus-like particle (VLP), and at least one CBV selected from CBV3, CBV4, and CBV5 in inactivated form or in the form of a subunit or a VLP, wherein the composition does not include CBV6, and wherein said administering induces an immune response to CBV in the pregnant woman.
CBV immune response composition for individual at increased T1D risk excluding CBV6
A method of inducing an immune response to CBV in an individual who is at increased risk of developing type 1 diabetes (T1D) by administering an effective amount of a composition comprising CBV1 and CBV2 in inactivated form or in the form of a subunit or a virus-like particle (VLP), and at least one CBV selected from CBV3, CBV4, and CBV5 in inactivated form or in the form of a subunit or a VLP, wherein the composition does not include CBV6, and wherein said administering induces an immune response to CBV in the individual.
Across both independent claims, the coverage is focused on inducing a CBV immune response using a defined multi-serotype CBV composition that always includes CBV1 and CBV2, includes at least one of CBV3/CBV4/CBV5, and explicitly excludes CBV6, with CBVs provided as inactivated forms, subunits, or VLPs.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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