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-10780157-B2
Publication Date
2020-09-22
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/composition for inducing an immune response in an individual against CBV, with emphasis on type 1 diabetes (T1D). The composition includes CBV1 and CBV2 in inactivated form or as a subunit or a virus-like particle (VLP), and at least one CBV selected from CBV3, CBV4, and CBV5, also in inactivated form or as a subunit or a VLP.
The composition explicitly excludes CBV6, and the immune response is targeted to individuals who are carriers of an HLA DR3 and/or DR4 allele. The rationale includes use of the CAR receptor and inter-serotype cross-protection via antibody-mediated cross-reactivity across CBV serotypes.
The background and supporting evidence presented in the partial content links CBV serotype risk with initiation of an autoimmune process relevant to T1D. Epidemiologic/seroneutralization analyses are reported to identify CBV1 and CBV2 as risk serotypes in a defined time window before autoantibody seroconversion, while CBV3/CBV6 are described as potentially protective or context-dependent, including sex-specific effects.
Claims Coverage
1 independent claim is provided in the partial content. The claim covers inducing an immune response to CBV by administering a defined multi-serotype CBV composition that includes CBV1 and CBV2 plus at least one of CBV3/CBV4/CBV5, while excluding CBV6, and restricting the target population by HLA DR3/DR4 carrier status.
Multi-CBV composition excluding CBV6 for immune response
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 administering induces an immune response to CBV in the individual.
HLA DR3 and/or DR4 carrier selection
The method wherein the individual is a carrier of an HLA DR3 and/or DR4 allele, and the administering induces an immune response to CBV in the individual.
The independent claim defines a targeted immune-response method using a multi-serotype CBV composition that includes CBV1 and CBV2 plus at least one of CBV3/CBV4/CBV5 while excluding CBV6, and applies to individuals carrying an HLA DR3 and/or DR4 allele.
Stated Advantages
Induces an immune response to CBV in an individual.
Documented Applications
Preventing or treating type 1 diabetes (T1D) by means of a multi-coxsackie B virus (CBV) vaccine/composition that induces an immune response to CBV.
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