Adjuvanted vaccines with non-virion antigens prepared from influenza viruses grown in cell culture

Patent metadata

Field	Value
Publication number	US-10842867-B2
Application number	US-9232506-A
Country	US
Kind code	B2
Filing date	Nov 6, 2006
Priority date	Nov 4, 2005
Publication date	Nov 24, 2020
Grant date	Nov 24, 2020

Abstract

An immunogenic composition comprising (i) a non-virion influenza virus antigen prepared from a virus grown in cell culture; and (ii) an adjuvant. Preferred adjuvants comprise oil-in-water emulsions.

First claim

The invention claimed is:

1. An immunogenic composition comprising:
(i) a purified surface antigen, prepared from a cell culture-grown human influenza virus; and
(ii) an adjuvant comprising an oil-in-water emulsion, wherein the composition is free from chicken DNA, ovalbumin and ovomucoid, and wherein the emulsion includes about 4.3% squalene by weight, about 0.5% polysorbate 80 by weight and about 0.48% sorbitan trioleate by weight and has sub-micron droplets.

2. The composition of claim 1 , comprising purified surface antigens from more than one human influenza virus strain.

3. The composition of claim 2 , wherein the purified surface antigens are prepared from human influenza A virus and human influenza B virus.

4. The composition of claim 1 , wherein the purified surface antigen is from an H1 H2, H3, H5, H7 or H9 influenza A virus subtype.

5. The composition of claim 1 , wherein the composition contains from 0.1 to 20 μg of haemagglutinin per viral strain in the composition.

6. The composition of claim 1 , wherein the composition contains less than 10 ng of cellular DNA from the cell culture host, per 15 μg of haemagglutinin.

7. The composition of claim 1 , wherein the composition includes a 3-O-deacylated monophosphoryl lipid A.

8. A method for preparing an immunogenic composition comprising the steps of combining:
(i) a purified surface antigen, prepared from a cell culture-grown human influenza virus; and
(ii) an adjuvant comprising an oil-in-water emulsion, wherein the composition is free from chicken DNA, ovalbumin and ovomucoid, and wherein the emulsion includes about 4.3% squalene by weight, about 0.5% polysorbate 80 by weight and about 0.48% sorbitan trioleate by weight and has sub-micron droplets.

9. A kit comprising:
(i) a first kit component comprising a purified surface antigen, prepared from a cell culture-grown human influenza virus; and
(ii) a second kit component comprising an adjuvant comprising an oil-in-water emulsion, wherein the first kit component is free from chicken DNA, ovalbumin and ovomucoid, and wherein the emulsion includes about 4.3% squalene by weight, about 0.5% polysorbate 80 by weight and about 0.48% sorbitan trioleate by weight and has sub-micron droplets.

10. An immunogenic composition comprising:
(i) a purified surface antigen, prepared from a cell culture-grown human influenza virus; and
(ii) an adjuvant comprising an oil-in-water emulsion and a tocopherol, wherein the composition is free from chicken DNA, ovalbumin and ovomucoid, and wherein the emulsion includes about 4.3% squalene by weight, about 0.5% polysorbate 80 by weight and about 0.48% sorbitan trioleate by weight and has sub-micron droplets.

11. The composition of claim 10 , wherein the purified surface antigen is from an H1, H2, H3, H5, H7, or H9 influenza A subtype.

12. An immunogenic composition comprising:
(i) a purified surface antigen, prepared from a cell culture-grown virus; and
(ii) an adjuvant comprising an oil-in-water emulsion, wherein the composition is a trivalent vaccine comprising influenza antigens from one H1N1 influenza A strain, one H3N2 influenza A strain and one influenza B strain, wherein the composition is free from chicken DNA, ovalbumin and ovomucoid, and wherein the emulsion includes about 4.3% squalene by weight, about 0.5% polysorbate 80 by weight and about 0.48% sorbitan trioleate by weight and has sub-micron droplets.

13. The composition of claim 1 , wherein the composition is substantially free from thiomersal.

14. The composition of claim 1 , wherein the composition is substantially free from mercurial material.

Assignees

• Rappuoli Rino
• Ohagan Derek
• Del Giudice Giuseppe
• Seqirus Uk Ltd

Inventors

• Rappuoli Rino
• O'Hagan Derek
• Del Giudice Giuseppe

Classifications

• A61K39/39 Primary

  characterised by the immunostimulating additives, e.g. chemical adjuvants · CPC title

• A61K39/145

  Orthomyxoviridae, e.g. influenza virus · CPC title

• C12N2760/16234

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N2760/16134

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• A61K2039/55566

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