Multi-CBV vaccine for preventing or treating type 1 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-11633468-B2
Publication Date
2023-04-25
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 disclosed invention relates to inducing an immune response to coxsackie B virus (CBV) in an individual at increased risk of developing type 1 diabetes (T1D). The invention administers an effective amount of a composition comprising CBV1 and CBV2 together with at least one additional CBV selected from CBV3, CBV4, CBV5, and CBV6.
The CBV antigens are provided in inactivated form or in the form of a subunit or a virus-like particle (VLP). The composition does not include any enterovirus or enterovirus VLP other than a CBV virus or CBV VLP, and administering induces an immune response to CBV in the individual.
The disclosed document further ties the serotypes to T1D risk/protection using reported study results and analyses, including an identified key time window before autoantibody seroconversion for CBV1 and CBV2, and sex-dependent risk trends for CBV6. It also discloses cross-neutralization among CBVs and includes preclinical examples using an inactivated CBV1 vaccine inducing neutralizing antibodies and protection from CBV1 viremia and pancreatic infection.
Claims Coverage
The independent claims cover four related methods for inducing an immune response to CBV using a multi-serotype CBV1 and CBV2 plus additional CBVs (CBV3 to CBV6) composition, with restriction to CBVs only and explicit inclusion of immune-response induction. Across the independent claims, four inventive feature themes are repeated: the CBV composition with specified serotypes and formats, exclusion of non-CBV enteroviruses, immune-response induction to CBV, and specified recipient context.
Multi-serotype CBV1 and CBV2 plus additional CBVs in inactivated, subunit, or VLP form
The method administering to the individual 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, CBV5, and CBV6 in inactivated form or in the form of a subunit or a VLP.
Excluding non-CBV enteroviruses and enterovirus VLPs
The composition does not include any enterovirus or enterovirus VLP other than a CBV virus or CBV VLP, wherein the method does not comprise administering any enterovirus or enterovirus VLP other than a CBV virus or a CBV VLP.
Inducing an immune response to CBV
The administering induces an immune response to CBV in the individual.
Recipient context: pregnant woman, or HLA DR3 and/or DR4 carrier, or increased-risk individual
The method is directed to an individual at increased risk of developing type 1 diabetes; a pregnant woman; or an individual who is a carrier of an HLA DR3 and/or DR4 allele.
Collectively, the independent claims define immune-response induction to CBV using a composition containing CBV1 and CBV2 plus at least one of CBV3 to CBV6 in inactivated form or as subunits or VLPs, while excluding non-CBV enteroviruses. They further scope the target population by including methods for increased-risk individuals, pregnant women, and individuals who carry HLA DR3 and/or DR4.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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