Immunisation of large mammals with low doses of RNA

Patent metadata

Field	Value
Publication number	US-10487332-B2
Application number	US-201113808153-A
Country	US
Kind code	B2
Filing date	Jul 6, 2011
Priority date	Jul 6, 2010
Publication date	Nov 26, 2019
Grant date	Nov 26, 2019

Abstract

RNA encoding an immunogen is delivered to a large mammal at a dose of between 2 μg and 100 μg. Thus the invention provides a method of raising an immune response in a large mammal, comprising administering to the mammal a dose of between 2 μg and 100 μg of immunogen-encoding RNA. Similarly, RNA encoding an immunogen can be delivered to a large mammal at a dose of 3 ng/kg to 150 ng/kg. The delivered RNA can elicit an immune response in the large mammal.

First claim

The invention claimed is:

1. A method of eliciting an antibody response and/or a cell-mediated immune response in a large mammal, comprising administering to the mammal a dose of between 2 μg and 100 μg of a self-replicating RNA encoding an immunogen, wherein the large mammal is a human, horse, cattle or pig and the RNA is formulated with a non-viral delivery system that comprises liposomes comprising a cationic lipid comprising a tertiary amine, wherein the self-replicating RNA: i) cannot perpetuate itself in infectious form and ii) includes no modified nucleotides other than a 5′ cap.

2. The method of claim 1 , wherein the RNA is administered to skeletal muscle tissue.

3. The method of claim 1 , wherein the RNA is administered by injection.

4. The method of claim 1 , wherein said RNA does not encode virion structural proteins.

5. The method of claim 1 , wherein the RNA is +-stranded.

6. The method of claim 1 , wherein the RNA encodes an immunogen which can elicit an immune response against a bacterium, a virus, a fungus or a parasite.

7. The method of claim 6 , wherein the immunogen can elicit an immune response in vivo against respiratory syncytial virus glycoprotein F.

8. The method of claim 1 , wherein the large mammal is a cow or a human.

9. The method of claim 1 , wherein said RNA induces production of IgG against said immunogen in said mammal.

10. The method of claim 1 , wherein the antibody and/or cell-mediated immune response is a protective immune response.

11. A method of eliciting an antibody response and/or a cell-mediated immune response in a large mammal, comprising administering to the mammal between 0.1 μg and 1.5 μg RNA per kg of the mammal's body weight, wherein the large mammal is a human, horse, cattle or pig and said RNA is a self-replicating RNA that encodes an immunogen, and wherein said RNA is formulated with a non-viral delivery system that comprises liposomes comprising a cationic lipid comprising a tertiary amine, wherein the self-replicating RNA: i) cannot perpetuate itself in infectious form and ii) includes no modified nucleotides other than a 5′ cap.

12. The method of claim 11 , wherein the RNA is administered to skeletal muscle tissue.

13. The method of claim 11 , wherein the RNA is administered by injection.

14. The method of claim 11 , wherein said RNA does not encode virion structural proteins.

15. The method of claim 11 , wherein the RNA is +-stranded.

16. The method of claim 11 , wherein said mammal is a human, cattle, horse, or pig.

17. The method of claim 11 , wherein the RNA encodes an immunogen which can elicit an immune response against a bacterium, a virus, a fungus or a parasite.

18. The method of claim 17 , wherein the immunogen can elicit an immune response in vivo against respiratory syncytial virus glycoprotein F.

19. The method of claim 11 , wherein the large mammal is a cow or a human.

20. The method of claim 11 , wherein said RNA induces production of IgG against said immunogen in said mammal.

Assignees

• Geall Andrew
• Glaxosmithkline Biologicals Sa

Inventors

• Geall Andrew

Classifications

• A61P37/04

  Immunostimulants · CPC title

• A61P33/00

  Antiparasitic agents · CPC title

• A61P31/12

  Antivirals · CPC title

• A61P31/10

  Antimycotics · CPC title

• A61P31/04

  Antibacterial agents · CPC title