# US 10,478,488 B2 · Liposomal flu vaccine formulation

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- Number: US 10,478,488 B2
- Document ID: US10478488B2
- Status: Granted
- Kind: B2
- Application number: 15/723,793
- Filed: 2017-10-03
- Published: 2019-04-04
- Granted: 2019-11-19
- Earliest claimed: 2017-10-03
- Assignees: Southwest Research Institute
- Applicants: Southwest Research Institute; The Ohio State University
- Inventors: Xingguo Cheng; Kenneth H. Carson; Joseph A. McDonough; Renukaradhya J. Gourapura; Chang Won Lee; Santosh Dhakal
- Web page: https://patentgrep.com/patent/US10478488B2

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/12: Viral antigens
- A61K 2039/55511: {Organic adjuvants}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- C12N 2760/16134: 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention relates to the field of pharmaceutical and vaccine formulations. More specifically, formulations which comprise an antigen comprising a mixture of oligopeptides loaded into liposome nanoparticles, optionally including an adjuvant, to provide an improved immune response.

## Claims

### Claim 1

An immunogenic composition comprising:
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 1;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 2;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 3;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 4;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 5;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 6;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 7;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 8;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 9; and
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 10.

### Claim 2 (depends on 1)

The immunogenic composition of claim 1 further comprising an adjuvant.

### Claim 3 (depends on 1)

The immunogenic composition of claim 1 wherein said adjuvant comprises mono sodium urate.

### Claim 4 (depends on 3)

The immunogenic composition of claim 3 wherein said mono sodium urate is present at a level of 1.0 mg to 10.0 mg.

### Claim 5 (depends on 1)

The immunogenic composition of claim 1 contained in a liposome nanoparticle.

### Claim 6 (depends on 5)

The immunogenic composition of claim 5 wherein said liposome nanoparticle has a diameter in the range of 50 nm to 200 nm.

### Claim 7 (depends on 5)

The immunogenic composition of claim 5 wherein said liposome nanoparticle has a Zeta potential in the range of −15.0 to −25 mV.

### Claim 8

An immunogenic composition comprising:
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 1;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 2;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 3;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 4;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 5;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 6;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 7;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 8;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 9; and
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 10; and
an adjuvant comprising mono sodium urate present at a level of 1.0 mg to 10.0 mg.

### Claim 9 (depends on 8)

The immunogenic composition of claim 8 contained in a liposome nanoparticle.

### Claim 10 (depends on 9)

The immunogenic composition of claim 9 wherein said liposome nanoparticle has a diameter in the range of 50 nm to 200 nm.

### Claim 11 (depends on 9)

The immunogenic composition of claim 9 wherein said liposome nanoparticle has a Zeta potential in the range of −15.0 to −25 mV.

### Claim 12

A method for eliciting an immune response and conferring protection against influenza virus in a subject, wherein the method comprises administering to the subject a vaccine comprising:
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 1;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 2;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 3;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 4;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 5;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 6;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 7;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 8;
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 9; and
an oligopeptide consisting of the sequence set forth by SEQ ID NO: 10;
to elicit an immune response and confer protection against influenza virus.

### Claim 13 (depends on 12)

The method of claim 12 wherein said vaccine further includes an adjuvant.

### Claim 14 (depends on 13)

The method of claim 13 wherein said adjuvant comprises mono sodium urate.

### Claim 15 (depends on 14)

The method of claim 14 wherein said mono sodium urate is present at a level of 1.0 mg to 10.0 mg.

### Claim 16 (depends on 12)

The method of claim 12 wherein said oligopeptides are contained in a liposome nanoparticle.

### Claim 17 (depends on 12)

The method of claim 12 wherein said liposome nanoparticle has a diameter in the range of 50 nm to 200 nm.

### Claim 18 (depends on 12)

The method of claim 12 wherein said liposome nanoparticle has a Zeta potential in the range of −15.0 to −25 mV.

### Claim 19 (depends on 12)

The method of claim 12 wherein the method of administration is subcutaneous, intramuscular, intravenous, intradermal, intranasal administration, or oral.