Vaccine comprising AMA1 and RON2

Patent metadata

Field	Value
Publication number	US-9795662-B2
Application number	US-201414902117-A
Country	US
Kind code	B2
Filing date	Jul 1, 2014
Priority date	Jul 1, 2013
Publication date	Oct 24, 2017
Grant date	Oct 24, 2017

Abstract

Disclosed is a vaccine comprising an immunogenic composition comprising a complex of AMA1 and RON2 (or a fragment thereof), which elicits an immune response to a Plasmodium species in a subject upon administration. The resulting immune response is sufficient to impede or prevent infection by a Plasmodium species.

First claim

What is claimed is:

1. A vaccine comprising: i) an immunogenic composition comprising a complex of AMA1 and RON2; and ii) at least one adjuvant.

2. A vaccine comprising: i) an immunogenic composition comprising a complex of: a) AMA1; and b) RON2 and/or a fragment thereof; and ii) at least one adjuvant.

3. The vaccine of claim 2 , wherein the composition elicits an immune response to a Plasmodium species in a subject upon administration to the subject.

4. The vaccine of claim 3 , wherein the immune response is sufficient to impede or prevent infection by a Plasmodium species.

5. The vaccine of claim 2 , wherein the vaccine is for the treatment of or protection from erythrocytic and/or pre-erythrocytic malaria infection in a subject.

6. The vaccine of claim 5 , wherein the treatment manifests itself in the subject as parasitemia being under control and/or the infection being cleared.

7. The vaccine of claim 3 , wherein the Plasmodium species is selected from the group consisting of Plasmodium falciparum, Plasmodium knowlesi, Plasmodium vivax, Plasmodium yoelii, Plasmodium malariae, Plasmodium ovale, Plasmodium brasilianum, Plasmodium cynomulgi, Plasmodium inui, Plasmodium rhodiani, Plasmodium schwetzi, Plasmodium semiovale , and Plasmodium simium.

8. A method of protecting a subject from erythrocytic malaria infection comprising administering a vaccine comprising: i) an immunogenic composition comprising a complex of: a) Plasmodium protein AMA1 or variant thereof; and b) Plasmodium protein RON2 and/or a fragment or variant thereof; wherein the variant has one or more naturally encoded amino acids deleted or replaced or has one or more amino acids added, without loss of a biological or immunological activity of the variant, wherein the biological activity comprises the ability of the two proteins or variants or fragments to hind to one another, and the immunological activity comprises the protective immunological activity of the complex; ii) at least one adjuvant and/or at least one physiologically acceptable carrier to the subject in an amount effective to stimulate an immune response, thus protecting the subject from erythrocytic malaria infection.

9. A method of protecting a subject from pre-erythrocytic malaria infection comprising administering a vaccine comprising: i) an immunogenic composition comprising a complex of: a) Plasmodium protein AMA1 or variant thereof; and b) Plasmodium protein RON2 and/or a fragment or variant thereof; wherein the variant has one or more naturally encoded amino acids deleted or replaced or has one or more amino acids added, without loss of a biological or immunological activity of the variant, wherein the biological activity comprises the ability of the two proteins or variants or fragments to bind to one another, and the immunological activity comprises the protective immunological activity of the complex; and ii) at least one adjuvant and/or at least one physiologically acceptable carrier to the subject in an amount effective to stimulate an immune response, thus protecting the subject from pre-erythrocytic malaria infection.

10. A method of protecting a subject from both erythrocytic and pre-erythrocytic malaria infection comprising administering a vaccine comprising: i) an immunogenic composition comprising a complex of: a) Plasmodium protein AMA1 or variant thereof; and b) Plasmodium protein RON2 and/or a fragment or variant thereof; wherein the variant has one or more naturally encoded amino acids deleted or replaced or has one or more amino acids added, without loss of a biological or immunological activity of the variant, wherein the biological activity comprises the ability of the two proteins or variants or fragments to bind to one another, and the immunological activity comprises the protective immunological activity of the complex; and ii) at least one adjuvant and/or at least one physiologically acceptable carrier to the subject in an amount effective to stimulate an immune response, thus protecting the subject from both pre-erythrocytic and erythrocytic malaria infection.

11. A method of protecting a subject from infection by a Plasmodium species comprising administering a vaccine comprising: i) an immunogenic composition comprising a complex of: a) Plasmodium protein AMA1 or variant thereof; and b) Plasmodium protein RON2 and/or a fragment or variant thereof; wherein the variant has one or more naturally encoded amino acids deleted or replaced or has one or more amino acids added, without loss of a biological or immunological activity of the variant, wherein the biological activity comprises the ability of the two proteins or variants or fragments to bind to one another, and the immunological activity comprises the protective immunological activity of the complex; and ii) at least one adjuvant and/or at least one physiologically acceptable carrier to the subject in an amount effective to stimulate an immune response, thus protecting the subject from infection with the Plasmodium species.

12. The method of claim 11 , wherein the vaccine is administered orally or parenterally.

13. The method of claim 11 , wherein the vaccine is administered with another active agent.

14. The method of claim 13 , wherein the agent is an antibiotic, antigen, or antibody.

15. A method for vaccinating a subject against a Plasmodium species comprising administering to the subject an effective amount of a vaccine comprising: i) an immunogenic composition comprising a complex of: a) Plasmodium protein AMA1 or variant thereof; and b) Plasmodium protein RON2 and/or a fragment or variant thereof; wherein the variant has one or more naturally encoded amino acids deleted or replaced or has one or more amino acids added, without loss of a biological or immunological activity of the variant, wherein the biological activity comprises the ability of the two proteins or variants or fragments to bind to one another, and the immunological activity comprises the protective immunological activity of the complex; and ii) at least one adjuvant and/or at least one physiologically acceptable carrier.

16. A method for generating protective antibodies in a subject against a Plasmodium species comprising administering to the subject an effective amount of a vaccine comprising: i) an immunogenic composition comprising a complex of: a) Plasmodium protein AMA1 or variant thereof; and b) Plasmodium protein RON2 and/or a fragment or variant thereof; wherein the variant has one or more naturally encoded amino acids deleted or replaced or has one or more amino acids added, without loss of a biological or immunological activity of the variant, wherein the biological activity comprises the ability of the two proteins or variants or fragments to bind to one another, and the immunological activity comprises the protective immunological activity of the complex; and ii) at least one adjuvant and/or at least one physiologically acceptable carrier.

17. A method for producing an immune response against a Plasmodium species in a subject comprising administering a vaccine comprising: i) an immunogenic composition comprising a complex of: a) Plasmodium protein AMA1 or variant thereof; and b) Plasmodium protein RON2 and/or a fragment or variant thereof; wherein the variant has one or more naturally encoded amino acids deleted or replaced or has one or more amino acids added, without loss of a biological or immunological activity of the variant, wherein the biological activity comprises the ability of the two proteins or variants or fragments to bind to one another, and the immunolog

Assignees

• Us Health

Inventors

• Srinivasan Prakash
• Miller Louis Howard

Classifications

• C07K16/205

  Plasmodium · CPC title

• A61K2039/55566

  Emulsions, e.g. Freund's adjuvant, MF59 · CPC title

• C07K14/445

  Plasmodium · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• C07K2319/00

  Fusion polypeptide · CPC title