Multi-CBV vaccine for preventing or treating type I diabetes
Inventors
Hyöty, Heikki • 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-11911456-B2
Publication Date
2024-02-27
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 patent describes a multi-CBV vaccine concept (CBV1–CBV6), framed as a means for preventing or treating type 1 diabetes (T1D). It addresses the problem that infections with coxsackie B virus (CBV) may be diabetogenic, and that different CBV serotypes show different associations with diabetes-related immune events, including autoantibody seroconversion.
The disclosed concept identifies CBV1 and CBV2 as diabetogenic risk serotypes, particularly in relation to infections occurring approximately 6–10 months before autoantibody seroconversion, while CBV3–CBV6 are described as having a more complex and potentially protective-or-risk profile. The approach includes serologic/statistical rationale for selecting serotypes and for inducing immune responses relevant to T1D risk.
The patent further supports inclusion of all six CBV serotypes by citing potential cross-protection and cross-reactive antibodies, and by noting shared receptor/tropism features among CBVs. It reports supporting experimental evidence including that inactivated CBV1 vaccination induces neutralizing antibodies and protects mice from CBV1 viremia and pancreatic infection, and that SOCS-1 transgenic NOD mice show CBV1-triggered beta-cell destruction/diabetes.
Claims Coverage
The partial content includes three independent claims, each covering inducing an immune response to coxsackie B virus (CBV) in a specific subject population by administering a nucleic-acid composition encoding viral antigenic epitopes for CBV1 and CBV2, and for at least one of CBV3–CBV5, while excluding CBV6.
Nucleic-acid composition with CBV1/CBV2 epitopes, CBV3–CBV5 epitopes, and exclusion of CBV6
Administering an effective amount of a composition comprising a nucleic acid encoding a protein or peptide comprising a viral antigenic epitope of CBV1 and a nucleic acid encoding a protein or peptide comprising a viral antigenic epitope of CBV2, and at least one nucleic acid selected from nucleic acids encoding viral antigenic epitopes of CBV3, CBV4, and CBV5, wherein the composition does not include a nucleic acid encoding a viral antigenic epitope of CBV6, wherein said administering induces an immune response to CBV.
Immune response induction in a pregnant woman
Inducing an immune response to CBV in a pregnant woman by administering an effective amount of the composition comprising CBV1 and CBV2 viral antigenic epitope nucleic acids plus at least one of CBV3–CBV5 viral antigenic epitope nucleic acids, excluding any nucleic acid encoding a CBV6 viral antigenic epitope, wherein said administering induces an immune response to CBV in the pregnant woman.
Immune response induction in a subject at increased risk of type 1 diabetes
Inducing an immune response to CBV in a subject who is at increased risk of developing T1D by administering an effective amount of the composition comprising CBV1 and CBV2 viral antigenic epitope nucleic acids plus at least one of CBV3–CBV5 viral antigenic epitope nucleic acids, excluding any nucleic acid encoding a CBV6 viral antigenic epitope, wherein said administering induces an immune response to CBV in the subject.
Immune response induction in an HLA DR3 and/or DR4 carrier
Inducing an immune response to CBV in a subject who is a carrier of an HLA DR3 and/or DR4 allele by administering an effective amount of the composition comprising CBV1 and CBV2 viral antigenic epitope nucleic acids plus at least one of CBV3–CBV5 viral antigenic epitope nucleic acids, excluding any nucleic acid encoding a CBV6 viral antigenic epitope, wherein said administering induces an immune response to CBV in the subject.
Across the independent claims, the core coverage is directed to inducing an immune response to CBV in defined subject groups using a nucleic-acid composition encoding CBV1 and CBV2 viral antigenic epitopes together with at least one of CBV3–CBV5, while excluding CBV6.
Stated Advantages
Documented Applications
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