# US 2019/0167786 A1 · Emulsions with free aqueous-phase surfactant for adjuvanting split influenza vaccines

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- Number: US 2019/0167786 A1
- Document ID: US20190167786A1
- Status: Published application
- Kind: A1
- Application number: 16/029,863
- Filed: 2018-07-09
- Published: 2019-06-06
- Earliest claimed: 2005-11-04
- Assignees: Seqirus UK Limited
- Applicants: Seqirus UK Limited
- Inventors: Derek O'Hagan
- Web page: https://patentgrep.com/patent/US20190167786A1

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61P 31/12: Antivirals
- A61P 31/16: for influenza or rhinoviruses
- A61P 37/04: Immunostimulants
- A61K 2039/55511: {Organic adjuvants}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A split influenza virus vaccine is adjuvanted with an oil-in-water emulsion that contains free surfactant in its aqueous phase. The free surfactant can continue to exert a ‘splitting effect’ on the antigen, thereby disrupting any unsplit virions and/or virion aggregates that might be present.

## Claims

### Claim at position 1

-34. (canceled)

### Claim 35

A method of raising an immune response in a human comprising administering a composition to the human, wherein the composition comprises a split influenza virus antigen and a squalene-in-water emulsion adjuvant, and wherein the squalene-in-water emulsion adjuvant includes free surfactant in its aqueous phase.

### Claim 36 (depends on 35)

The method of claim 35, wherein the split influenza virus antigen is from a H1, H2, H3, H5, H7, or H9 influenza A virus subtype.

### Claim 37 (depends on 35)

The method of claim 35, wherein the split influenza virus antigen is derived from an influenza virus strain grown in cell culture, and wherein the composition is free of ovalbumin, ovomucoid, and chicken DNA.

### Claim 38 (depends on 37)

The method of claim 37, wherein the composition contains less than 10 ng of host cell DNA.

### Claim 39 (depends on 35)

The method of claim 35, wherein the squalene-in-water emulsion adjuvant comprises alpha-tocopherol.

### Claim 40 (depends on 35)

The method of claim 35, wherein the squalene-in-water emulsion adjuvant comprises Polysorbate 80 in its aqueous phase.

### Claim 41 (depends on 35)

The method of claim 35, wherein the squalene-in-water emulsion adjuvant comprises a 3-O-deacylated monophosphoryl lipid A.

### Claim 42 (depends on 35)

The method of claim 35, wherein the squalene-in-water emulsion adjuvant has droplets with a sub-micron diameter.

### Claim 43 (depends on 35)

The method of claim 35, wherein the composition includes split influenza virus antigens derived from two influenza A strains and one influenza B strain.

### Claim 44 (depends on 35)

The method of claim 35, wherein the composition is a monovalent vaccine against a pandemic influenza virus strain.

### Claim 45

A method of reducing antigen aggregate in an immunogenic vaccine comprising admixing a split influenza virus antigen with a squalene-in-water emulsion adjuvant to form the immunogenic vaccine, wherein the squalene-in-water emulsion adjuvant includes free surfactant in its aqueous phase.

### Claim 46 (depends on 45)

The method of claim 45, wherein the split influenza virus antigen is from a H1, H2, H3, H5, H7, or H9 influenza A virus subtype.

### Claim 47 (depends on 45)

The method of claim 45, wherein the split influenza virus antigen is derived from an influenza virus strain grown in cell culture, and wherein the immunogenic vaccine is free of ovalbumin, ovomucoid, and chicken DNA.

### Claim 48 (depends on 47)

The method of claim 47, wherein the immunogenic vaccine contains less than 10 ng of host cell DNA.

### Claim 49 (depends on 45)

The method of claim 45, wherein the squalene-in-water emulsion adjuvant comprises alpha-tocopherol.

### Claim 50 (depends on 45)

The method of claim 45, wherein the squalene-in-water emulsion adjuvant comprises Polysorbate 80 in its aqueous phase.

### Claim 51 (depends on 45)

The method of claim 45, wherein the squalene-in-water emulsion adjuvant comprises a 3-O-deacylated monophosphoryl lipid A.

### Claim 52 (depends on 45)

The method of claim 45, wherein the squalene-in-water emulsion adjuvant has droplets with a sub-micron diameter.

### Claim 53 (depends on 45)

The method of claim 45, wherein the immunogenic vaccine includes split influenza virus antigens derived from two influenza A strains and one influenza B strain.

### Claim 54 (depends on 45)

The method of claim 45, wherein the immunogenic vaccine is a monovalent vaccine against a pandemic influenza virus strain.