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Title:
VACCINES AND IMMUNOGLOBULINS TARGETING AFRICAN SWINE FEVER VIRUS, METHODS OF PREPARING SAME, AND METHODS OF USING SAME
Document Type and Number:
WIPO Patent Application WO/2021/062212
Kind Code:
A4
Abstract:
The present disclosure provides a method of isolating and preparing live African Swine Fever (ASF) viruses (ASFV) and an ASFV vaccine composed of whole ASF virus particles, viral components, and/or immunosuppressive protein factors. The ASFV vaccine can be used to immunize pigs and wild boars, or can be used to immunize species other than pig or wild boar, such as fowl, bovine, goat, rabbit, donkey or horse, to generate polyclonal immunoglobulins with broad-spectrum specificity to the ASFV. The ASFV-specific immunoglobulins then can be extracted and purified. The ASFV-specific immunoglobulins can provide acute treatment of ASF-infected pigs or wild boars or preventative treatment for pigs or wild boars at risk of ASF, for example that may have been exposed to ASFV or ASFV-infected subjects.

Inventors:
NGUYEN HUAN HUU (US)
Application Number:
PCT/US2020/052805
Publication Date:
May 20, 2021
Filing Date:
September 25, 2020
Export Citation:
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Assignee:
IGY IMMUNE TECH AND LIFE SCIENCES INC (US)
International Classes:
A61K39/00; A61K39/12; A61K39/395; C07K16/08; C12N7/00; C12N15/09
Attorney, Agent or Firm:
MORROW, Aaron J. (US)
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Claims:
AMENDED CLAIMS received by the International Bureau on 26 April 2021 (26.04.2021)

Claim 1 : A method of treating African swine fever (ASF) viral (ASFV) infection in an infected pig or wild boar, the method comprising administering to the infected pig or wild boar an effective amount of a composition comprising IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors.

Claim 2: The method of Claim 1, wherein the composition is administered in an amount that provides a dose of the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors that is about 0.5 mg to about 1.0 mg per kg body weight of the infected pig or wild boar.

Claim 3 : The method of Claim 1 , wherein the composition comprising the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors is administered for a time period comprising at least once per week or 7 consecutive days.

Claim 4: The method of Claim 1, wherein the composition comprising the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors is administered parenterally by intramuscular or intraperitoneal injection.

Claim 5: The method of Claim 1, wherein the composition comprising the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors is a food product administered orally.

Claim 6: A method of preventing, decreasing incidence of, and/or decreasing severity of ASF viral infection in a pig or wild boar at risk thereof, the method comprising administering to the pig or wild boar an effective amount of a composition comprising IgY immunoglobulins

36 specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors.

Claim 7: The method of Claim 6, wherein the composition is administered in an amount that provides a dose of the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors that is about 0.5 to about 1.0 mg per kg of body weight of the pig or wild boar at risk thereof.

Claim 8: The method of Claim 6, wherein the composition comprising the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors is administered for a time period comprising at least once per week or 7 consecutive days.

Claim 9: The method of Claim 6, wherein the composition comprising the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors is administered parenterally.

Claim 10: The method of Claim 6, wherein the composition comprising the IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors is a food product administered orally.

Claim 11: A method of producing ASFV-specific immunoglobulins wherein a ASFV vaccine comprised of whole live ASF virus particles, naturally expressed ASF viral components, and/or immunosuppressive protein factors, is administered to a non-swine species host for ASFV-specific immunoglobulin production.

Claim 12: The method of Claim 11, wherein the host is an egg-laying fowl.

Claim 13: A unit dosage form comprising a therapeutically or prophylactically effective amount of a composition comprising IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors. Claim 14: The unit dosage form of Claim 13, wherein the composition is a food product formulated for oral administration.

Claim 15: A method of preventing, decreasing incidence of, and/or decreasing severity of ASF viral infection in a pig or wild boar at risk thereof, the method comprising administering to the pig or wild boar an effective amount of an ASFV vaccine composition comprising (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors.

Claim 16: The method of Claim 15, wherein the naturally expressed ASF viral components and whole live ASF virus particles are inactiv[e]ated using gamma irradiation.

Claim 17: The method of Claim 15, wherein the ASFV vaccine composition is administered parenterally by intramuscular or intraperitoneal injection.

Claim 18: The method of Claim 15, wherein the ASFV vaccine composition is administered in an amount that provides a dose of the naturally expressed ASF viral components that is about 0.05 mg to about 1.0 mg per pig or wild boar.

Claim 19: A unit dosage form comprising an effective amount of an ASFV vaccine composition comprising naturally expressed ASF viral components, whole live ASF virus particles, and/or immunosuppressive protein factors.

Claim 20: The unit dosage form of Claim 19, wherein the naturally expressed ASF viral components and whole live ASF virus particles are derived from ASF-infected spleen mononuclear cells (SMNCs), ASF-infected peripheral blood and mononuclear cells (PBMCs), and/or ASF-infected primary alveolar macrophages (PAMs).

Claim 21: The unit dosage form of Claim 19, wherein the naturally expressed ASF viral components are inactivated using gamma irradiation.

Claim 22: ASFV vaccine, comprising IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors for use in the treatment and/or prevention of ASF infection in a pig or wild boar at risk thereof. Claim 23: A composition comprising IgY immunoglobulins specific against (a) naturally expressed ASF viral components, (b) whole live ASF virus particles, and/or (c) immunosuppressive protein factors for use in the treatment and/or prevention of ASF infection in a pig or wild boar at risk thereof.

Claim 24: The method of Claim 1, wherein the naturally expressed ASF viral components, whole live ASF virus particles, and/or immunosuppressive protein factors are derived from cells, tissues, and/or organs of an ASFV-infected pig or wild boar.

Claim 25: The method of Claim 1, wherein the naturally expressed ASF viral components and whole live ASF virus particles are inactivated by gamma irradiation.

Claim 26: The method of Claim 6, wherein the naturally expressed ASF viral components, whole live ASF virus particles, and/or immunosuppressive protein factors are derived from cells, tissues, and/or organs of an ASFV-infected pig or wild boar.

Claim 27: The method of Claim 11, wherein the naturally expressed ASF viral components, whole live ASF virus particles, and/or immunosuppressive protein factors are derived from cells, tissues, and/or organs of an ASFV-infected pig or wild boar.

Claim 28: The method of Claim 13, wherein the naturally expressed ASF viral components, whole live ASF virus particles, and/or immunosuppressive protein factors are derived from cells, tissues, and/or organs of an ASFV-infected pig or wild boar.

Claim 29: The method of Claim 13, wherein the naturally expressed ASF viral components and whole live ASF virus particles are inactivated by gamma irradiation.

Claim 30: The unit dosage form of Claim 19, wherein the naturally expressed ASF viral components, whole live ASF virus particles, and/or immunosuppressive protein factors are derived from ASF-infected spleen mononuclear cells (SMNCs) and/or ASF-infected peripheral blood and mononuclear cells (PBMCs).

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