# US 11,305,005 B2 · Methods of use of influenza vaccine for prevention of pneumonia

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- Number: US 11,305,005 B2
- Document ID: US11305005B2
- Status: Granted
- Kind: B2
- Application number: 15/738,417
- Filed: 2016-06-23
- Published: 2018-06-28
- Granted: 2022-04-19
- Earliest claimed: 2015-06-24
- Assignees: Sanofi Pasteur Limited
- Applicants: Sanofi Pasteur, Inc.
- Inventors: Carlos DiazGranados; Andrew Dunning
- Web page: https://patentgrep.com/patent/US11305005B2

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/12: Viral antigens
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2760/16034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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
- 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
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

This application relates to the field of prevention of pneumonia by administration of a high-dose influenza vaccine.

## Claims

### Claim 1

A method for preventing pneumonia in a subject comprising: (a) identifying a subject at risk of serious pneumonia; and (b) administering an influenza vaccine to the subject, wherein the dose of influenza vaccine administered to the subject is higher than a standard-dose influenza vaccine, wherein the vaccine is administered for active immunization against pneumonia in the subject, wherein the pneumonia is caused by a virus, bacterium, or fungus, and wherein the pneumonia is serious pneumonia.

### Claim 2

A method of preventing pneumonia in a subject comprising: (a) identifying a subject at risk of serious pneumonia; and (b) administering an influenza vaccine to the subject, wherein (i) the content of one or more influenza protein(s) in the influenza vaccine is higher than the content of the influenza protein(s) in a standard-dose influenza vaccine, wherein said influenza protein(s) are selected from HA, NA, M1, M2, PB1, PB2, PA, NS1, NS2, and NP; and/or (ii) the influenza vaccine provides more antigen to the subject as compared to a standard-dose influenza vaccine, wherein the antigen is one or more of HA, NA, M1, M2, PB1, PB2, PA, NS1, NS2, and NP, wherein the pneumonia is caused by a virus, bacterium, or fungus, and wherein the pneumonia is serious pneumonia.

### Claim 3 (depends on 1)

The method of claim 1, wherein the pneumonia is caused by a virus selected from influenza virus, respiratory syncytial virus (RSV), metapneumovirus, adenovirus, rhinovirus, coronavirus varicella-zoster virus, and parainfluenza virus; the pneumonia is caused by a bacterium selected from Streptococcus pneumoniae, Staphylococcus aureus, Neisseria meningitides, Mycoplasma pneumonia, Haemophilus influenae, Legionella pneumonia, Legionella spp., Chlamydia spp., including Chlamydia pneumonia and Chlamydia psittaci, Moraxella spp., including Moraxella catarrhalis, Streptococcus pyogenes, including Streptococcus pyogenes Pseudomonas aeruginosa, gram-negative enteric bacilli, methicillin-susceptible S. aureus, methicillin-resistant S. aureus, Haemophilus parainfluenae, Haemophilus parahaemolyticus, Pseudomonas alcaligenes, Citrobacter freundii, Staphylococcus haemolyticus, Clostridium perfringens, anaerobes, including Fusobacterium sp., Prevotella sp., Gemella morbillorum, Peptostreptococcus prevotii, Veillonella sp., Nocardia sp., coagulase-negative Staphylococci, and Acinetobacter baumannii; the pneumonia is caused by a fungus associated with at least one of histoplasmosis, coccidioidomycosis, blastomycosis, pneumocystis pneumonia, sporotrichosis, cryptococcosis, aspergillosis, candidiasis, or scedoporiosis; the pneumonia is caused by a virus and a bacterium; or the pneumonia is caused by infection with influenza virus.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pneumonia is a community-acquired pneumonia (CAP).

### Claim 5 (depends on 1)

The method of claim 1, wherein the pneumonia is a healthcare-associated pneumonia.

### Claim 6 (depends on 1)

The method of claim 1, wherein the pneumonia is not preceded by influenza.

### Claim 7 (depends on 3)

The method of claim 3, wherein the pneumonia is preceded by, or concurrent with influenza.

### Claim 8 (depends on 2)

The method of claim 2, wherein the vaccine administered to the subject has a haemagglutinin (HA) content that is higher than the HA content of a standard-dose influenza vaccine, and/or the vaccine administered to the subject has a neuraminidase (NA) content that is higher than the NA content of a standard-dose influenza vaccine.

### Claim 9 (depends on 1)

The method of claim 1, wherein the vaccine administered to the subject is a trivalent vaccine or a quadrivalent vaccine.

### Claim 10 (depends on 1)

The method of claim 1, wherein the vaccine administered to the subject is produced in avian eggs, is made by recombinant DNA techniques, is inactivated or live attenuated, and/or is administered intradermally, intramuscularly, or intranasally.

### Claim 11 (depends on 1)

The method of claim 1, wherein the vaccine administered to the subject contains adjuvant.

### Claim 12 (depends on 2)

The method of claim 2, wherein the vaccine administered to the subject is a reformulated version of a vaccine selected from Fluzone (Trivalent or Quadrivalent; Sanofi Pasteur), Fluarix (Trivalent or Quadrivalent; intradermal; GlaxoSmithKline), FluLaval (Trivalent or Quadrivalent; ID Biomedical Corporation of Quebec; distributed by GlaxoSmithKline), Alfluria (bioCSL), Fluvirin (Novartis Vaccines and Diagnostics), Flucelvax (Novartis Vaccines and Diagnostics), FluMist (MedImmune), and FluBlok (Protein Sciences), wherein the reformulated vaccine has a higher dose than the standard dose version.

### Claim 13 (depends on 2)

The method of claim 2, wherein the HA content of the vaccine administered to the subject is higher than about 15, 20, 24, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, or 90 micrograms of HA per strain per dose.

### Claim 14 (depends on 2)

The method of claim 2, wherein the vaccine administered to the subject is formulated to have a higher HA content than the HA content of a standard-dose vaccine.

### Claim 15 (depends on 2)

The method of claim 2, wherein the vaccine administered to the subject is formulated to have a higher NA content than the NA content of a standard-dose vaccine.

### Claim 16 (depends on 1)

The method of claim 1, wherein the subject is about 65 years of age or older or the subject is a child that is about 18 years of age or younger.

### Claim 17 (depends on 1)

The method of claim 1, wherein the subject is an adult that is about 18 years of age or older and younger than about 65 years of age.

### Claim 18 (depends on 1)

The method of claim 1, wherein the subject is immune-compromised, the subject is a pregnant woman, the subject has or had asthma, diabetes, heart disease, HIV, AIDS, or cancer, and/or the subject is younger than 5 years, 4 years, 3 years, 2 years, 1 year, or 6 months.

### Claim 19 (depends on 1)

The method of claim 1 wherein the pneumonia is caused by a non-influenza pathogen.

### Claim 20

A method for preventing pneumonia caused by a non-influenza pathogen in a subject comprising: (a) identifying a subject at risk of pneumonia; and (b) administering an influenza vaccine to the subject, wherein the dose of influenza vaccine administered to the subject is higher than a standard-dose influenza vaccine, wherein the vaccine is administered for active immunization against pneumonia in the subject, and wherein the pneumonia is caused by a non-influenza virus, bacterium, or fungus.

### Claim 21 (depends on 20)

The method of claim 20, wherein the pneumonia is not preceded by or concurrent with influenza.