Vaccine Compositions Comprising a Saponin Adjuvant

• US 20110206758A1
• Filed: 02/03/2011
• Published: 08/25/2011
• Est. Priority Date: 12/13/2005
• Status: Active Grant

• Current Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Original Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Inventors: Vandepapeliere, Pierre
• Granted Patent: US 10,039,823 B2
• Time in Patent Office: Days
• US Class Current: 424/450
• CPC Class Codes: A61K 2039/5258 Virus-like particles
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/55 characterised by the host/recipient, e.g. newborn with maternal antibodies
• CPC Class Codes: A61K 2039/55505 Inorganic adjuvants
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/55572 Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
• CPC Class Codes: A61K 2039/55577 Saponins; Quil A; QS21; ISCOMS
• CPC Class Codes: A61K 2039/57 characterised by the type of response, e.g. Th1, Th2
• CPC Class Codes: A61K 2039/6037 Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
• CPC Class Codes: A61K 2039/6068 Other bacterial proteins, e.g. OMP
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/015 Hemosporidia antigens, e.g. Plasmodium antigens
• CPC Class Codes: A61K 39/092 Streptococcus
• CPC Class Codes: A61K 39/102 Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
• CPC Class Codes: A61K 39/1045 Moraxella
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 31/16 : for influenza or rhinoviruses
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 31/20 : for DNA viruses
• CPC Class Codes: A61P 31/22 : for herpes viruses
• CPC Class Codes: A61P 33/06 : Antimalarials
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C12N 2710/10134 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2710/16134 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2710/16171 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2710/16734 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2710/16771 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2710/20071 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2730/10134 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16134 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16171 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2760/16234 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16271 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2760/20034 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention provides a human dose of an immunogenic composition comprising an antigen or antigenic preparation, in combination with an adjuvant which adjuvant comprises an immunologically active saponin fraction derived from the bark of Quillaja Saponaria Molina presented in the form of a liposome and a lipopolysaccharide wherein said saponin fraction and said lipopolysaccharide are both present in said human dose at a level of below 30 μg. The present invention further provides an adjuvant composition in a human dose suitable volume comprising between 1 and 30 μg of a lipopolysaccharide and between 1 and 30 μg of an immunologically active saponin fraction presented in the form of a liposome.

Claims

1. A method of vaccination of a human individual or population comprising delivery of an antigen or antigenic preparation, in combination with an adjuvant which adjuvant comprises an immunologically active saponin fraction derived from the bark of Quillaja Saponaria Molina presented in the form of a liposome and a lipopolysaccharide wherein said saponin fraction and said lipopolysaccharide are both present in said human dose at a level of below 30 μ

g.

2. The method according to claim 1 wherein said adjuvant further comprises a sterol, wherein the ratio of saponin:

sterol is from 1;

1 to 1;

100 w/w.

3. The method according to claim 2 wherein the ratio of saponin:

sterol is from 1;

1 to 1;

10 w/w.

4. The method according to claim 2 wherein the ratio of saponin:

sterol is from 1;

1 to 1;

5 w/w.

5. The method according to claim 1 wherein said immunologically active saponin fraction is QS21.

6. The method according to claim 2 wherein said sterol is cholesterol.

7. The method according to claim 1 wherein said lipopolysaccharide is a lipid A derivative.

8. The method according to claim 7 wherein said lipid A derivative is 3D-MPL.

9. The method according to claim 8 wherein the ratio of QS21:

3D-MPL is 1;

1.

10. The method according to claim 1 wherein said lipopolysaccharide is present at an amount of 1-30 μ

g.

11. The method according to claim 10 wherein said lipopolysaccharide is present at an amount of 25 μ

g.

12. The method according to claim 10 wherein said lipopolysaccharide is present at an amount of 1-15 μ

g.

13. The method according to claim 12 wherein said lipopolysaccharide is present at an amount of 10 μ

g.

14. The method according to claim 12 wherein said lipopolysaccharide is present at an amount of 5 μ

g.

15. The method according to claim 1 wherein said saponin is present at an amount of 1-25 μ

g.

16. The method according to claim 15 wherein said saponin is present at an amount of 25 μ

g.

17. The method according to claim 15 wherein said saponin is present at an amount of 1-10 μ

g.

18. The method according to claim 17 wherein said saponin is present at an amount of 10 μ

g.

19. The method according to claim 17 wherein said saponin is present at an amount of 5 μ

g.